IDSA News - January 2011
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CLSI Publishes New Breakpoints for Antimicrobial Susceptibility Testing
The Clinical and Laboratory Standards Institute (CLSI) has published new breakpoints for antimicrobial susceptibility testing. IDSA members are encouraged to review the new/revised CLSI breakpoints, assess their impact on patient management, and work with laboratories to implement the breakpoints as appropriate to optimize treatment of infectious diseases in your institution.
In June 2010, CLSI published new minimal inhibitory concentration (MIC) and disk diffusion interpretive criteria (i.e., breakpoints) for the Enterobacteriaceae for five cephalosporins, including first-generation and third-generation (extended-spectrum) cephalosporins, aztreonam, and for three carbapenems (imipenem, meropenem, and ertapenem). CLSI also published initial breakpoints for doripenem. The new MIC breakpoints are one to three doubling dilutions lower than the original breakpoints, and the new disk diffusion criteria include larger zone diameters than those in previous guidelines. Thus, many organisms that would have been categorized previously as susceptible using the former breakpoints may now be considered intermediate or resistant.
Please visit IDSA’s website for an alert with more information, including the critical issue of when and how the revised CLSI breakpoints will be implemented in clinical microbiology laboratories, particularly in the United States, and what role IDSA members can play in this process. This alert was developed under the auspices of IDSA’s Antimicrobial Resistance Work Group.
Please review the entire alert on antimicrobial susceptibility testing, including the additional references, before proceeding with any changes. For additional information, please contact CLSI at email@example.com.
CDC Issues Guidance on Pre-Exposure Prophylaxis for HIV Prevention
The Centers for Disease Control and Prevention (CDC) recently released interim guidance for the use of pre-exposure prophylaxis (PrEP) for the prevention of HIV infection in men who have sex with men. Available online, the guidance appears in the Jan. 28 Morbidity and Mortality Weekly Report (MMWR). This guidance follows the results of the iPrEx trial released in November 2010, which examined whether a pill containing drugs used to treat HIV could also help prevent HIV in men who have sex with men (see IDSA News article).
In a response to the guidance, the HIV Medicine Association (HIVMA) noted that CDC was right to call for careful screening and monitoring of patients prescribed PrEP but that the guidance missed the mark in not recommending referral to an HIV expert. HIVMA also noted that this intervention underscores the need to maintain and grow the HIV medical workforce to meet the needs of patients, the importance of treating those already infected with HIV to help prevent new infections, and the unaddressed issue of who will pay for PrEP.
CDC will hold an hour-long telebriefing for providers on Feb.1 at 12 p.m. EST to discuss the guidance. To register for the call, visit this website. For additional information and resources, please see CDC’s PrEP webpage.
Additional Practice Guidelines Now Available as Pocketcards
Guidelines formatted for mobile devices also available
Pocket-sized quick-reference guides are now available for the following IDSA practice guidelines: catheter-associated bacteriuria, antimicrobial stewardship, pneumococcal immunization, and IDSA’s new guidelines for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections (see related article) and for fever and neutropenia in cancer patients (see related article). To view electronic previews and to order the 4-by-7-inch Pocketcards, visit IDSA’s website. IDSA members are eligible for a 35 percent discount when ordering. Use discount code DCIDSA11.
In addition, guidelines covering intra-abdominal infections are now available in a format designed for iPhones and other mobile devices. Visit the Society’s website for instructions on downloading and using these guidelines on an iPhone or other mobile device.
Drug Approvals, Recalls, Adverse Events Update
IDSA offers two e-mail services to help members stay informed of updates from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Content includes a range of topics, including new drug approvals and warnings. Recent alerts have included:
IDSA members can sign up for these services online. (You must be logged in to have access to this link.)
Is Your Facility Experiencing Antibiotic Shortages?
Report these to FDA and IDSA.
PQRS and E-Prescribing Resources for ID Physicians
Includes details on how to qualify for Medicare incentive payments and avoid penalties
Updated information to help ID physicians and their practices qualify for Medicare incentive payments for reporting quality measures and for electronic prescribing (eRx) is now available on IDSA’s website. These incentives will be replaced by penalties, as the Centers for Medicare and Medicaid Services (CMS) moves to pay physicians differentially based on the quality and cost of their care.
Physicians must start participating in the eRx program this year to qualify for a 1 percent incentive payment. At least 25 electronic prescriptions during 2011 are required to qualify for the incentive. Providers who do not submit at least 10 electronic prescriptions on their Medicare claims during the first six months of 2011 (by June 30) will see their payments cut by 1 percent beginning in 2012.
IDSA’s “Quality Improvement Resources and Tools” webpage has additional details, including:
- eRx reporting options and measure specifications
- available hardship exemptions from eRx requirements and how to request them
- a link to download free eRx software, which may be a good interim option for practices that need a short-term solution to avoid payment penalties and provide time to implement an EHR system with eRx capabilities
- an explanation of how the eRx program relates to Medicare’s requirements for meaningful use of EHRs
Under the Physician Quality Reporting System (PQRS), physicians may increase their total Medicare payments in 2011 by 1.0 percent by successfully reporting on applicable quality measures. These incentive payments will drop to 0.5 percent from 2012 to 2014. Starting in 2015, eligible physicians who do not report will see a 1.5 percent penalty. IDSA encourages members to begin reporting through PQRS before payment penalties begin.
Visit IDSA’s website for more information about PQRS, such as:
- details on PQRS reporting options
- how to fill out Medicare claim forms to ensure accurate reporting
- lists of qualified registries and electronic health record (EHR) vendors for PQRS reporting
- quality measures reportable by ID specialists
- examples of how the reporting options and quality measures may apply to different service mixes and patient populations
- where to go for more assistance, including a PQRS telephone and e-mail help line
The “Physician Compare” website developed by Medicare and available to the public currently shows whether a particular physician reported on PQRS measures. Later in 2011, the site will include eRx reporting information, and in future years, additional quality/cost indicators for physicians. It is critical that physicians verify the accuracy of demographic information from Medicare’s Internet-based Provider Enrollment, Chain, and Ownership System (PECOS) as this information is included on the Physician Compare website.
Check IDSA’s website for updates on these and other quality reporting tools and requirements. Members may also contact Jason Scull of IDSA staff with additional questions.
Physicians Excluded from FTC’s Identity Theft Rule
Physician practices have been excluded from a Federal Trade Commission (FTC) rule that would have required them to have policies in place protecting against patients’ identity theft or face a fine.
FTC’s “Red Flags Rule” requires creditors to protect clients’ personal identifying information, such as insurance information, from being used fraudulently. FTC originally considered physician practices to be creditors, but the American Medical Association (AMA) and others disagreed with this interpretation and filed suit to prevent FTC from extending the rule to physicians. In December 2010, President Obama signed legislation into law that excludes physicians from the rule.
Prior to the legislation’s passage, the deadline for practices to have such policies in place—or face a fine of $2,500—was extended several times throughout 2009 and 2010.
New Report Calls for Expanded Use of Male Circumcision to Prevent HIV
Medical male circumcision (MC) is a proven, one-time, cost-effective intervention for preventing new HIV infections and should be expanded, according to a new issue brief from the Center for Global Health Policy. Studies of MC in sub-Saharan Africa have already shown that MC can reduce a man’s chance of acquiring HIV through vaginal sex by up to 60 percent.
The Center’s report, “Medical Male Circumcision as HIV Prevention, Follow the Evidence: The case for aggressive scale up,” supports rapidly expanding MC services in countries with high HIV prevalence, low rates of MC, and a predominantly heterosexual epidemic. If fully implemented, MC can save millions of lives and significant resources, says the report, which summarizes the research in this area and outlines strategies for implementation.
“This monograph discusses best practices and highlights some of the recent successes in enhancing access to MC,” said Kenneth H. Mayer, MD, FIDSA, director of the Brown University AIDS Program and co-chair of the Center for Global Health Policy’s Scientific Advisory Committee. “MC is the first biomedical intervention with demonstrated efficacy for HIV prevention, but making it accessible to populations where the epidemic is expanding has proven to be challenging.”
The issue brief is available to download from the Center’s website. Additional print copies for distribution can be obtained from Center staff at no cost. Read more about the report and MC on the Center’s blog, Science Speaks.
Other recent blog updates include:
- Calling on President Barack Obama to remember the vital importance of global AIDS funding when finalizing his new budget request, 25 prominent leaders in the field of public health placed a half-page ad in Politico, a Capitol Hill newspaper, in December. The ad asked the president to significantly increase funding for the President’s Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria. See the related blog post for more about the ad).
- Zeke Emanuel, MD, PhD, has left the White House Office of Management & Budget and returned to his post at the National Institutes of Health (NIH), where he serves as head of the Department of Bioethics at the Clinical Center of the NIH. Kaiser Health News and Politico reported the move. Dr. Emanuel took part in several Science Speaks posts that generated discussion among global health experts, including an Oct. 2010 post on tuberculosis treatment that generated this response.
FDA Releases Data on Antibiotic Use on the Farm
Nearly 29 million pounds of antimicrobials were sold and distributed for use in animal agriculture in 2009, according to a first-ever report released in December by the Food and Drug Administration (FDA). The FDA report, which is based on data submitted by drug manufacturers, breaks down the data by different drug classes. The report and a related question-and-answer document are available online.
Of the antibiotics sold in 2009 that are used in both humans and food animals, almost 80 percent were for use in animal agriculture, according to an analysis from the Center for a Livable Future based on FDA’s report and additional data obtained from the agency.
FDA released the data, contained in a brief, four-page report, following legislation passed in 2008 directing the agency to do so annually. IDSA and other organizations had advocated for this data to be collected and reported publicly, in light of the scientific evidence demonstrating that antibiotic use in food animals contributes to the spread of resistant bacteria to humans and leads to drug-resistant infections. IDSA and many of these groups also support legislation, the Preservation of Antibiotics for Medical Treatment Act (PAMTA), which would appropriately limit non-judicious uses of antibiotics in agriculture.
In its Q&A document, FDA noted that “because more use of antimicrobials is, in general, associated with greater levels of resistance, these data will supplement the FDA’s ongoing activities in antimicrobial resistance prevention.”
Although the report is a good first step, IDSA believes more detailed information on the use of antimicrobials in both humans and in animals is needed. The Strategies to Address Antimicrobial Resistance (STAAR) Act, which IDSA and more than 25 other organizations have endorsed, contains solutions that would help address this need, in addition to providing improved coordination and funding of federal activities.
IDSA Continues to Weigh In on Consultation Codes
IDSA expressed concerns about Medicare’s decision to eliminate physician payments for consultation codes during a January meeting of the Medicare Payment Advisory Commission (MedPAC).
Daniel McQuillen, MD, FIDSA, chair of IDSA’s Clinical Affairs Committee, testified on behalf of IDSA, joining representatives from several cognitive specialties. Dr. McQuillen noted the negative effect of the decision on both ID physician practices and patient access. Dr. McQuillen also mentioned the need to develop payment incentives for infection control and systems-level activities commonly overseen by infectious diseases specialists. A transcript of the meeting, including Dr. McQuillen’s testimony, is available online.
A survey by the American Medical Association found that 95 percent of ID respondents said their total revenue stream has decreased since the policy went into effect in January 2010 (see IDSA News article.) With a regulatory fix unlikely, IDSA and others who want to restore payments for consultations continue to seek a legislative remedy, which is high on IDSA’s agenda.
Other advocacy updates include:
- In December, IDSA responded to Medicare’s release of its 2011 Physician Fee Schedule Final Rule. In its comments, the Society continued to oppose the decision to eliminate payments for consultation codes and urged Medicare to reassess its decision not to cover all preventive vaccines under Medicare Part B. See this IDSA News article for a detailed look at the payment changes in the final rule and how they will affect you.
- The HIV Medicine Association (HIVMA) underscored the need for payment models that reflect the cost of providing chronic, complex care in recent comments to the Centers for Medicare and Medicaid Services (CMS). HIVMA also urged CMS to support a pilot under the new Center for Medicare and Medicaid Innovation to document and evaluate, in terms of patient outcomes and cost of care, the Ryan White model for patient-centered medical home care.
- In testimony delivered in January, HIVMA urged an Institute of Medicine (IOM) committee examining Medicare reimbursement issues to consider payment mechanisms that will support the HIV medical home care model currently supported with Ryan White funding.
Members on the Move
Michael S. Saag, MD, FIDSA, was awarded the 2010 University of Alabama at Birmingham (UAB) President’s Medal in December 2010 in recognition of his role as a leader and pioneer in AIDS research. One of the highest honors bestowed by UAB, the President’s Medal recognizes individuals who have attained scholarly distinction and/or have rendered distinguished service to the university.
Dr. Saag holds the Jim Straley Endowed Chair in AIDS Research and directs the William C. Gorgas Center for Geographic Medicine and the Center for AIDS Research. He currently serves on the International AIDS Society-USA Board of Directors, is a member of the Department of Health and Human Services (HHS) Guidelines Panel on Antiretroviral Therapy, and serves on numerous state, local, and national committees. Dr. Saag is the immediate past chair of the HIV Medicine Association (HIVMA).
Welcome, New Members!
Butler-Wu, Susan, PhD
Chang, Kathleen, MD
Clarke, Diana, PharmD
Coers, Jorn, PhD
DeLiberto, Thomas, PhD, DVM
Guarner, Jeannette, MD
Jabes, Daniela, PhD
Joshi, Avni, MD
Kohli, Rahul, MD, PhD
Martin, Harold, MD, MPH
Montano, Monty, PhD
Reuben, Allen, MD
Shah, Maunank, MD
Thottingal, Paul, MD
Yang, Soojin, PhD
Alarie, Isabelle, MD
Bing, Caryn, MS, RPh
Burgess, Colleen, MS
Dunsworth, Teresa, PharmD
Hasham, Mohamed, MD
Hinch, Michelle, RPh
Konnor, Rebecca, MPH, PhD
Kunzer, Bethaney, NP, RN
Laskin, Margaret, FNP
Love, William, PhD
Ma, Richard, MD
McNeil, Andrew, MD
Naikwade, Sonal, MD, MBBS
Pieroni, Peter, PhD
Quatannens, John, MD
Roberts, Kim, BSN, MS, RN
Scott, Kimberley, BSN, RN
Spencer, Christie, DNSc
Thompson, Elizabeth, MSN, NP, RN
Torti, Carlo, MD
Walker, Sandra, PharmD
Westbrook, Kimberly, MD
Widemond, Tomas, MPH
Anyimadu, Henry, MD
Assefa, Daniel, MD
Auguste, Antonie, MD
Borba, Julie, MD
De la Cabada, Javier, MD
DiNardo, Andrew, MD
Dorairajan, Sureshkumar, MD
Gagliardo, Christina, MD
George, Lisa, MD
Grigor, Laura, MD
Haman, Timothy, MD
Harris, Samuel, MD
Howard, Leigh, MD
Keller, Brenna, DO
Kyei, George, ChB, MB, PhD
Marko, Daniel, MD
Mohamed, Abdi, PharmD
Njoku, Emmanuel, MD
Nudelman, Yuliya, MD
Offner, Stuart, MD
Ordaya, Eloy, MD
Punzalan, Cecile, MD, MPH
Rahman, Mateen, MBBS
Ramanan, Poornima, MD
Rosado-Odom, Vera, MD
Saadia, Naseem, MD
St. Clair, Kristina, DO
Stockamp, Nathan, MD
Stroud, Steven, MD
IDSA Influenza Conference Available Online, with CME Credit
IDSA members can register for free to view sessions from IDSA’s Seasonal and Pandemic Influenza 2011 conference online. While the conference took place Jan. 27-28, if you were unavailable on these dates, you can still view the sessions on-demand and earn CME credits.
This year’s program featured an array of topics including epidemiology, cross-cutting issues like communication, antiviral deployment, and infrastructure and surge. Speakers addressed:
- the international impact of pandemic and seasonal influenza
- new pandemic and seasonal influenza planning strategies, including the role of state and public health officials
- the improvement of public-private sector coordination efforts, particularly related to vaccine developments
Participants included members of the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), state and local health officials, and ID professionals.
The conference aims to identify domestic scientific and policy developments and discuss specific needs of resource-poor countries. The meeting will result in recommendations for future research and intervention for unmet needs, and in recommendations for how the developing world can address pandemic priorities.
For more information, visit www.idsalive.com.
New Fellowship in Transplant ID Available: 2011 Joint Research Awards
The IDSA Education and Research Foundation (ERF) and the National Foundation for Infectious Diseases (NFID) have added a new Postdoctoral Fellowship in Transplant ID to the list of Joint Research Awards for 2011. The award is available through funding from Astellas Pharma US, Inc. One award will be given, and the recipient will receive $25,000 a year for two years (the total award is $50,000).
This award will allow a selected individual to receive advanced training in the pathogenesis of infection, including topics such as: molecular virology, the role of infection in the pathogenesis of graft rejection, novel models or therapies of infectious diseases, and the development of assays for microbial agents. The fellow will benefit from the opportunity to be associated with a senior mentor who will assist the trainee in career planning and research program development. The two-year period of the fellowship will allow the trainee to find a research focus and an opportunity to develop preliminary data to support applications for independent funding for his or her future career.
The deadline for applications is March 15. More information regarding requirements and eligibility for the Joint Research Awards, including application details, can be found at www.idsociety.org/jointresearchawards.htm.
Online CME Available: Antimicrobial Stewardship in a Community Hospital
A free CME activity outlining practical tools and techniques for implementing antimicrobial stewardship programs at community hospitals is available online at Medscape. The activity features a panel of leading ID specialists, hospitalists, and health system pharmacists discussing the latest information about the most relevant issues related to the challenges, current management, and latest developments for implementation of antimicrobial stewardship principles at nonteaching community hospitals.
The scientific roundtable meeting was presented by the Centers for Disease Control and Prevention (CDC). Cooperating organizations include IDSA, the Society for Healthcare Epidemiology of America (SHEA), the American Medical Association (AMA), the Association for Professionals in Infection Control and Epidemiology (APIC), the Society of Hospital Medicine (SHM), and the Society of Infectious Diseases Pharmacists (SIDP).
After completing the activity, participants should be better able to:
- evaluate the principles and objectives of an antimicrobial stewardship program
- identify the barriers to implementing a successful stewardship program in a community hospital
- list the key elements of an antimicrobial stewardship program for a community hospital
- integrate evidence-based practices and resources to improve antimicrobial use
- facilitate interaction with the medical staff at the health care facility to promote acceptance of a stewardship program
The program can be found on Medscape at: cme.medscape.com/viewprogram/31823. It was jointly sponsored by the University of Cincinnati, the Potomac Center for Medical Education, and Rockpointe®. The program was was supported by an educational grant from Ortho-McNeil™ Inc.
ABIM Foundation Grants Available for Medical Professionalism Efforts
The American Board of Internal Medicine (ABIM) Foundation will award several grants in 2011 providing financial support to organizations working to advance medical professionalism, specifically related to appropriate health care decision-making and stewardship of health care resources.
The grants are available to professional medical organizations, health systems/hospitals, academic medical centers and medical practices, and other organizations as they work to advance medical professionalism. A total of five grants of up to $20,000 each will be awarded in 2011. The deadline for applications is March 31.
Visit the ABIM Foundation website for more information, including how to apply.
From the President: The Intersection of Human and Animal Health
Recognizing the importance of the fundamental linkages between human and animal health, and their relevance to public health, concerned members of both disciplines are urging greater interdisciplinary collaboration and communication, under an approach known as “One Health.”
At the 48th Annual Meeting of IDSA in October, I had the privilege of moderating two press conferences highlighting some of the notable abstracts presented in Vancouver. One of these, presented by Charles Y. Chiu, MD, from the University of California-San Francisco, identified a novel adenovirus as the cause of a deadly outbreak of pneumonia and hepatitis in a Titi monkey colony. The virus also appeared to have infected a researcher, who fortunately survived. The abstract is available online.
These findings were another small but important reminder of the convergence of people, animals, and the environment that inextricably links the health of everyone on the planet. According to one study, over the past 70 years, more than 60 percent of emerging infections have been zoonotic diseases resulting from cross-species transmission. Some examples include AIDS, hantavirus pulmonary syndrome, SARS, and avian and pandemic influenza.
Recognizing the importance of these fundamental linkages and their relevance to public health, concerned members of both the human and animal health disciplines are urging greater interdisciplinary collaboration and communication, under an approach known as “One Health.”
Cooperation between human and animal health experts can only improve the surveillance, diagnosis, treatment, prevention, and control of cross-species transmission and emerging infections. During the SARS outbreak, for example, it quickly became apparent that the veterinary community’s knowledge of animal coronaviruses would be helpful in the understanding of and response to the emergence of this new coronavirus in people. This surely won’t be the last time such collaboration is beneficial.
In May 2010, in an effort to create an opportunity for dialogue around zoonotic disease issues in the spirit of “One Health,” IDSA invited several members of the veterinary and animal health communities to take part in a meeting of the Society’s National and Global Public Health Committee, chaired by Deborah Cotton, MD, MPH, FIDSA. There was a robust discussion about ways IDSA could increase collaboration with its veterinary partners. More discussions are planned.
This past fall, the committee also added a veterinary member, Marguerite Pappaioanou, DVM, MPVM, to represent the “One Health” philosophy and the Association of American Veterinary Medical Colleges, where she serves as executive director. Dr. Pappaioanou’s input to this committee, currently chaired by Ruth Lynfield, MD, FIDSA, will be helpful as IDSA continues to explore collaborations with its partners in animal health.
In another example of the strong connections between human and animal health, in late 2010 the American Veterinary Medical Association joined more than 25 other medical societies and organizations that have endorsed IDSA’s 10 x ’20 initiative, which calls for the development of 10 new antibiotics by 2020. We welcome this endorsement, as it will take the involvement and support of many stakeholders across many disciplines to achieve the initiative’s important goal.
As part of the Society’s efforts to address antibiotic resistance, IDSA also continues to advocate for judicious use of antibiotics in clinical settings and on farms to help protect patients and the general public against antibiotic-resistant infections. In December 2010, following efforts by IDSA and other organizations, the Food and Drug Administration released for the first time estimates of the amount of antibiotics sold for use in domestic food animal production. For more information, please see the related article in this issue of IDSA News.
This month’s newsletter also features several other noteworthy IDSA updates:
- New details about how to qualify for Medicare physician payment incentives—and how to avoid potential payment penalties in the future—as health care reform legislation is implemented are now available on the IDSA website.
- IDSA’s Seasonal and Pandemic Influenza meeting was held Jan. 27-28 in Arlington, Va., and an online on-demand webcast of the program, including the opportunity to earn CME credit, is now available. The planning committee, led by Richard Whitley, MD, FIDSA; Arnold Monto, MD, FIDSA; and Kathleen Neuzil, MD, MPH, FIDSA, with the assistance of Andrew Pavia, MD, FIDSA, chair of IDSA’s Pandemic Influenza Task Force, developed an excellent program examining lessons learned from the H1N1 pandemic that will result in the updating of IDSA’s Pandemic and Seasonal Influenza Principles for U.S. Action.
As these updates show, the Society’s important work continues, focusing on the needs of a diverse membership and providing valuable resources to members.
IDSA Releases Guideline for Treatment of MRSA Infections
IDSA’s first-ever practice guideline for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in adults and children is now available.
IDSA’s first-ever practice guideline for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in adults and children is now available. The guideline can be found online and also appears in the Feb. 1 issue of Clinical Infectious Diseases.
The IDSA guideline addresses a variety of infections caused by MRSA commonly encountered by ID specialists, emergency room physicians, pediatricians, primary care physicians, hospitalists, pharmacists, and other health care providers. Topics include:
- how to manage skin and soft tissue infections likely caused by community-associated MRSA;
- how to treat recurrent skin infections;
- recommendations regarding use of vancomycin and other antibiotics used for the treatment of MRSA;
- how to manage invasive infections, such as pneumonia, and infections in the bones, joints, blood, or heart;
- how to treat newborns who are infected with MRSA.
“MRSA has become a huge public health problem, and physicians often struggle with how to treat it,” said Catherine Liu, MD, lead author of the guideline and assistant clinical professor in the Division of Infectious Diseases, University of California, San Francisco. “The guideline establishes a framework to help physicians determine how to evaluate and treat uncomplicated as well as invasive infections. It’s designed to be a living document, meaning the recommendations will evolve as new information and antibiotics become available.”
In addition to the treatment recommendations, the guideline identifies critical gaps where funding of research is needed to advance clinical treatment and care of MRSA infections. Several performance measures for internal performance improvement for the management and treatment of such infections are also included.
The guideline was reviewed and endorsed by the Pediatric Infectious Diseases Society (PIDS), the American College of Emergency Physicians (ACEP), and the American Academy of Pediatrics (AAP).
The guideline is available online and in a pocket-sized quick-reference format (see related IDSA News article). Other IDSA guidelines also are available on the Standards, Practice Guidelines, and Statements page of our website.
Updated IDSA Guideline on Fever and Neutropenia
An updated IDSA guideline provides guidance for treating cancer patients who develop either fever of unknown etiology or documented infections during chemotherapy-induced neutropenia.
An updated IDSA guideline for the use of antimicrobial agents in neutropenic cancer patients with fever is now available online. The guideline, previously updated in 2002, appears in the Feb. 15 issue of Clinical Infectious Diseases.
Recommendations provide guidance for clinicians treating cancer patients who develop either fever of unknown etiology or documented infections during chemotherapy-induced neutropenia. Recent improvements in antimicrobial drug development, diagnostic technology, and clinical management have led to a highly comprehensive, updated guideline. The document defines infection risk levels for neutropenic patients (high or low) based upon signs and symptoms present at the onset of fever, and outlines specific treatment algorithms for high- and low-risk patients.
In addition, the guideline indicates which patients are likely to benefit from antibiotic, antifungal, and antiviral prophylaxis. Also included is guidance regarding:
- defining characteristics of high-risk and low-risk patients with fever and neutropenia
- what tests and cultures should be performed during the initial assessment
- how antimicrobials should be modified during the course of fever and neutropenia
- the duration of antibiotic prophylaxis and selection of agents
“Cancer patients with fever and neutropenia are not a uniform group who can all be managed in the same fashion,” said Alison Freifeld, MD, lead author of the guideline and professor of medicine at the University of Nebraska Medical Center in Omaha. “Our aim has been to bring some evidence-based order to the variabilities in presentation, infection source, and management approaches that clinicians are going to encounter.”
Information about the management of indwelling central venous catheters (CVCs) that become infected is a new addition to the guideline, as are recommended environmental precautions for neutropenic patients. Tables and figures also provide standards of management and empirical regimens for patients with fever and neutropenia.
Important performance measures in the guideline include:
- Patients with fever and neutropenia should be evaluated based on specific criteria (e.g., levels of risk, history, and physical examinations).
- Antimicrobial changes to the empirical antibiotic regimen should be based on clinical, radiographic, or microbiological evidence of the infection.
- Low-risk patients with an anticipated short duration of neutropenia (<7 days) do not require antibiotic prophylaxis.
The guideline is available online and in a pocket-sized quick-reference format (see related IDSA News article). Other IDSA guidelines also are available on the Standards, Practice Guidelines, and Statements page of our website.
IDSA Journal Club
This month, studies investigating: the efficacy of two doses of varicella vaccine, the use of rifaximin for irritable bowel syndrome, pre-exposure prophylaxis for HIV prevention, an update on the impact of foodborne illnesses, and short- versus long-term antimicrobial treatment for acute hematogenous osteomyelitis in children.
In this feature, a panel of IDSA members identifies and critiques important new studies in the current literature that have a significant impact on the practice of infectious diseases medicine.
Click here for the previous edition of Journal Club. For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, in each issue of Clinical Infectious Diseases.
The Evidence Is In: Two Doses of Varicella Vaccine Are Better Than One
Reviewed by Christian B. Ramers, MD, MPH
After a varicella vaccine was licensed in the U.S. in 1995, disease incidence, hospitalizations and mortality all fell significantly. However, outbreaks occurred in schools and daycare settings despite high vaccination rates, and even immunized children continued to contract “breakthrough” varicella. Based on data showing better antibody responses, but without controlled data on comparative clinical efficacy, the Centers for Disease Control and Prevention recommended a second vaccine dose for children aged 4-6 years old in 2006. A report in the February 1 issue of The Journal of Infectious Diseases fills this gap in evidence.
Investigators conducted a case-control study (71 cases and 140 matched controls) drawing from 28 pediatric practices in southern Connecticut. They identified cases using active surveillance and confirmed varicella zoster virus (VZV) with DNA PCR on vesicular fluid. Authors verified vaccination status using a thorough medical records review.
Among the 71 PCR-confirmed cases, 5 (7 percent) had not received varicella vaccine, 66 (93 percent) had received one dose, and none had received two doses. Among the 140 controls, one (0.7 percent) had not received the varicella vaccine, 117 (83.6 percent) had received one dose, and 22 (15.7 percent) had received two doses. The authors calculated an effectiveness of 86.0 percent for one dose of vaccine and 95 percent for two doses (p < 0.001). Further, the odds of developing varicella disease in those who had received two doses were 95 percent lower than those who had received only one.
This study provides strong evidence supporting the recommendation for routine administration of two doses of varicella vaccine. Continued surveillance for all forms of VZV disease, including reactivation disease, will be essential because latent infection with wild-type VZV is likely to decline with ongoing vaccination and long-term efficacy of the vaccine is unknown.
(Shapiro et al. J Infect Dis. 2011 Feb; 203(3): 312-5.)
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Yet Another Potential Use for Rifaximin: Irritable Bowel Syndrome
Reviewed by Christopher J. Graber, MD MPH
Rifaximin, a rifamycin antibiotic with low systemic absorption following oral administration, has emerged as a viable treatment option for hepatic encephalopathy and travelers’ diarrhea. An article published in the January 6 issue of the New England Journal of Medicine may add irritable bowel syndrome (IBS) without constipation to this list.
This study, funded by the manufacturer of rifaximin, enrolled 1,260 patients into one of two identical randomized trials in which participants who had a diagnosis of IBS without constipation and active symptoms received a two-week course of rifaximin 550 mg or placebo twice daily for 14 days. Patients in the rifaximin arm had statistically significant (though moderate) improvement relative to placebo in most endpoints over the following 10 weeks (improvement in global IBS symptoms, bloating, abdominal pain, and stool consistency), an effect that diminished over time with respect to some symptoms.
Infectious diseases practitioners should be aware of IBS as an additional potential indication for rifaximin use, as rifaximin’s high cost (more than $20 per 550 mg pill) and the potential for IBS patients to receive multiple two-week courses may strain antibiotic formulary budgets. What is less clear is how widespread rifaximin use may contribute to rifamycin resistance. While significant increases in rifamycin resistance among gut flora with rifaximin use have largely not been seen to date, a study in the January 2011 issue of Journal of Infection examines whether rifaximin use in healthy volunteers predisposed to rifampin resistance among staphylococci colonizing their skin.
Of the 11 volunteers who took a seven-day course of rifaximin (none of whom were colonized with rifampin-resistant staphylococci at baseline), seven were colonized with rifampin-resistant staphylococci at some point during their 10-week follow up. Resistance was seen earliest among isolates colonizing the perianal region. While the rifampin-resistant staphylococci, all of which were coagulase-negative, constituted only 2 percent of all of the staphylococci isolated throughout the study, this study highlights potential danger ahead, as rifampin is frequently used in adjunctive treatment of certain invasive staphylococcal diseases.
(Pimentel et al. New Engl J Med 2011; 364(1):22-32 and Valentin et al. J Infect 2010;62(1):34-38)
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HIV Pre-Exposure Prophylaxis with Tenofovir/FTC: iPrEx Study Proves Concept
Reviewed by Nina Kim, MD, MSc
The past year has witnessed encouraging advancement in HIV prevention. The CAPRISA 004 study showed a 39 percent reduction in the risk of HIV acquisition among women who used a tenofovir-based vaginal gel before and after sex. Joining these data are the long-awaited results of the landmark trial on the efficacy of oral antiretroviral therapy (ART) for the prevention of HIV (the Preexposure Prophylaxis Initiative, or iPrEx, study), published in the December 30 issue of the New England Journal of Medicine.
The trial randomized 2,499 HIV-seronegative men who have sex with men to receive the oral once-daily coformulation of tenofovir-emtricitabine (TDF/FTC) or placebo. Participants also received condoms and underwent adherence and risk-reduction counseling as well as rapid serum HIV testing by enzyme-linked immunoassay every four weeks.
Of the 100 HIV infections that occurred during the median 1.2 years of follow-up, 64 occurred in the placebo group and 36 in the treatment group with an overall risk reduction of 44 percent (95 percent confidence interval, 15-63 percent, P=0.005). As in the CAPRISA study, efficacy correlated with greater drug exposure, with a 73 percent risk reduction at the highest adherence category. Subjects tolerated TDF/FTC well; adverse events and discontinuations were similar between groups, though reversible elevations in serum creatinine occurred more often in those in the treatment than placebo arm (25 versus 14 subjects). Emtricitabine resistance was noted in three men who had acute HIV infection at enrollment; two of these were in the TDF/FTC group.
While the results of the iPrEx study represent a major step in HIV prevention research, it is uncertain how ART-based pre-exposure prophylaxis will play out in real-world settings. The optimal administration of TDF/FTC in the context of other prevention tools, the benefit to other risk groups, and the extent of drug resistance and nephrotoxicity with widespread implementation all remain unclear. In the wake of this study, the Centers for Disease Control and Prevention (CDC) has issued interim guidance on the use of pre-exposure prophylaxis (PrEP) as an HIV prevention strategy among men who have sex with men.
(Grant et. al. N Engl J Med 2010; 363:2587-99.)
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An Update on the Impact of Foodborne Illnesses
Reviewed by Rachel Simmons, MD
Two recent studies illustrated the significant impact of foodborne illnesses locally and nationally. In the December 15 issue of Clinical Infectious Diseases, researchers report on a raw milk-related outbreak of E. coli 0157:NM associated with a farm in Connecticut where the sale of raw milk is legal. The investigation identified seven definite and seven probable cases, and the median age of the cases was 5. One adult was hospitalized with thrombotic thrombocytopenic purpura (TTP), and three children were hospitalized with hemolytic uremic syndrome (HUS).
The investigation revealed no major regulatory infractions on the farm, and E. coli O157:NM was isolated from the stool of an asymptomatic cow. The estimated cost of the outbreak was $413,402. An advisory at the point of sale described the risks of consuming unpasteurized milk, and at least in the case-control portion of the study, the cases (or their parents) stated they knew that the unpasteurized milk can contain harmful bacteria.
In the January 2011 issue of Emerging Infectious Diseases, researchers report on the overall burden of foodborne illness in the United States. They estimated that 31 pathogens cause 9.4 million foodborne illnesses (59 percent due to viruses, 39 percent due to bacteria, and 2 percent due to parasites) leading to 55,961 hospitalizations and 1,351 deaths annually. In a second study, the investigators estimated that unknown or unspecified foodborne pathogens acquired in the U.S. cause 38.4 million illnesses, 71,878 hospitalizations, and 1,686 deaths each year. In combination, 47.8 million foodborne illnesses occur in the U.S. each year.
These studies indicate that the food supply remains an important and costly cause of morbidity and mortality. In early January, President Obama signed food safety legislation into law giving the Food and Drug Administration greater authority to both prevent and manage foodborne outbreaks. Adequately funding the implementation of the bill may be challenging, but these studies underscore the urgent need for better food safety practices.
(Guh et al. Clin Infect Dis. 2010; 51:1411-7, Scallan et al. Emerg Infect Dis. 2011;17:7-15, and Scallan et al. Emerg Infect Dis. 2011;17:16-22.)
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Short- Versus Long-Term Antimicrobial Treatment for AHOM in Children
Reviewed by Ed Dominguez, MD
Acute hematogenous osteomyelitis (AHOM) in childhood has traditionally been treated for four or more weeks, initially with intravenous antibiotics. A study published in the December 2010 issue of the Pediatric Infectious Disease Journal has evaluated the duration and route of therapy in a prospective, randomized trial for the first time.
Investigators evaluated short-term (20 days) versus long-term (30 days) therapy in 131 culture-positive patients from 1993 to 2005. The children ranged in age from 3 months to 15 years old. Patients were randomized to receive either clindamycin or first-generation cephalosporin therapy, intravenously for two to four days, followed by oral therapy until the termination date. Erythrocyte sedimentation rate, peripheral white blood count, and C-reactive protein (CRP) level were also monitored.
Sixty-seven patients were in the short-term group, 64 in the long-term group. Staphylococcus aureus accounted for 89 percent (n=117) isolates; all were methicillin-susceptible. At the end of therapy, there were no significant deviations between the groups in the parameters measured. Although more patients received clindamycin than cephalosporins, there was no difference in response. Seventy-six percent of patients required surgical intervention, but there was no difference in the need for surgery between groups. After 12 months, no patient required corrective osteotomy. The authors conclude that 20-day therapy for AHOM, initially intravenously for several days with high doses of a highly absorbable antibiotic, is appropriate if there is symptomatic improvement and normalization of the CRP within 10 days.
An adjoining editorial notes that the lack of community-acquired methicillin-resistant (CA-MRSA) in this study is important. A number of AHOM studies in children infected with such strains show that these patients are more likely to have prolonged bacteremia and fever, and have more than one bone or joint involved. They are also more likely to require intensive care. Additionally, the CRP may take 19 days or longer to normalize in these patients. Before employing short-term therapy, the clinician must rule out infection with these virulent strains.
(Peltola et al. Ped Inf Dis J. 2010;29:1123-1128 and Kaplan. Ped Inf Dis J. 2010;29:1128-1129.)
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For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, in each issue of Clinical Infectious Diseases:
- Eliminating Leprosy
- A Carbapenemase From Abroad: NDM-1
- Oseltamivir Resistance—Mutations Hiding in the Background Account for its Spread
- Non-Antibiotic Therapy of Uncomplicated Cystitis