IDSA News - February 2011
The Emerging Infections Network (EIN) is a forum for infectious diseases consultants and public health officials to report information on clinical phenomena and epidemiological issues with public health significance. Any diagnostic or therapeutic recommendations and all opinions presented are those of the individual contributor. They do not necessarily represent the views of EIN, IDSA (EIN’s sponsor), or the Centers for Disease Control and Prevention (CDC), which funds the EIN. The reader assumes all risks in using this information.
In several discussions during the past two years, EIN members have raised questions about cerebrospinal fluid shunts, extraventricular drains, and the use of antimicrobial prophylaxis for infection control in these procedures. The responses have highlighted a range in practice in these areas and a need for additional data.
In April of 2009, an EIN member in Ohio asked about current practices for antibiotic prophylaxis, including antibiotic choice and duration, for extraventricular drains. “Our surgeons prefer to continue antibiotics until the drains are out,” the member wrote. “Each has a particular combo that makes more or less sense.”
But “given scant data and the fact that our recommendation to discontinue the antibiotics within 24 hours of surgery is backed up by 15-year-old guidelines but no clear statement in regards to neurosurgical procedures,” the member asked for input from other EIN members.
A New Jersey member, one of only two respondents, wrote that “our pediatric neurosurgeons use prophylaxis for as long as the drain is in place,” with oxacillin being used unless the patient is known to have methicillin-resistant Staphylococcus aureus (MRSA) or is penicillin allergic, in which case vancomycin is used. “We were not involved in the development of their care plan,” the respondent noted.
In June of 2010, an Ohio member asked for “input on the choice of antibiotic for pre-surgical prophylaxis for VP [ventriculo-peritoneal] shunt placement in both the neonatal age group and beyond.”
Draft therapeutic guidelines, available online, include antibiotic prophylaxis recommendations for neurosurgery procedures, a respondent in Georgia wrote. The American Society of Health-System Pharmacists (ASHP), IDSA, the Surgical Infection Society, and the Society for Healthcare Epidemiology of America are collaborating on these guidelines, which should be completed later this year. For more information, see the ASHP website.
In January of 2011, an EIN member in Florida described a request from neurosurgery colleagues “who want to use one dose of intraventricular vancomycin and gentamicin at time of VP shunt placement. I have used these two agents on rare occasions as a therapeutic alternative,” the member wrote, “but not as a prophylactic agent. Any experience with intraventricular antibiotics prophylaxis?”
Although practiced by some neurosurgeons, a Texas respondent replied that this was not standard therapy and not an approved use of the medication by the Food and Drug Administration.
In another discussion in January of 2009, an EIN member in Georgia asked for comments on infection control practices for VP shunt placement in infants and children, including pre-operative bathing, soaking portions of shunts in antibacterial solution, and irrigation, among other related topics. A respondent in Iowa replied that in her facility, bathing was not used in these cases, and shunts were irrigated with bacitracin. “Our surgeons use antibiotic impregnated catheters,” the member wrote. “Some staff inject gentamicin into the reservoir after it is placed.”
As in the other discussions, however, the lack of other respondents suggests a need for more supporting data for this important clinical topic.
The Emerging Infections Network (EIN) is a provider-based sentinel network designed to help the public health community detect trends in emerging infectious diseases.
A joint project of IDSA and the Pediatric Infectious Diseases Society (PIDS) with funding from the Centers for Disease Control and Prevention (CDC), EIN tracks emerging infectious diseases and keeps the public health community up to date with new disease trends, difficult cases, and other issues affecting members’ clinical practices. The Network provides a great opportunity for members to share knowledge quickly across large geographical distances. Both IDSA and PIDS members are eligible to join. Click here for more information or to join EIN.
The U.S. Supreme Court has ruled that people who believe they were injured by improperly designed vaccines must rely on the compensation system that Congress created in the 1980s and may not sue vaccine manufacturers.
The Feb. 22 ruling was applauded by immunization advocates, including the American Academy of Pediatrics (AAP), which had filed an amici curiae (friends of the court) brief that IDSA and 20 other health organizations signed onto last year. (See IDSA News, July/August 2010.)
Congress created the Vaccine Injury Compensation Program—known as the Vaccine Court—in 1986 as a no-fault alternative to compensate the families of children who suffer from rare adverse reactions caused by vaccines, and to protect the nation’s vaccine supply, which had been threatened at the time by mounting lawsuits and rising insurance premiums.
“Today’s ruling preserves the Vaccine Court … as the first entry point for families seeking compensation for injuries caused by childhood vaccines,” said an AAP press release. “By providing an avenue for vaccine injury claims separate from the traditional litigation process, the Vaccine Court has expedited compensation for families in need, prevented manufacturers from abandoning the vaccine market, and ensured a stable supply of vaccines to protect against countless childhood diseases.”
Read the Supreme Court ruling at: www.supremecourt.gov/opinions/10pdf/09-152.pdf.
In response to recent pertussis outbreaks, the federal Advisory Committee on Immunization Practices (ACIP) at its February meeting recommended that all health care workers (HCW) regardless of age should receive a single dose of the tetanus, diphtheria, and pertussis (Tdap) vaccine as soon as possible, if they have not previously received it.
The revised guidance updates a previous recommendation that advised vaccination as soon as possible for health care personnel with direct patient contact and for other HCWs at a recommended interval. To fill in pertussis vaccination gaps, the committee in October 2010 also recommended a single dose of Tdap vaccine for adults 65 years of age and older who have close contact with infants less than one year old.
At February’s meeting, the committee also approved an update of general immunization recommendations for HCWs, which advise that workers should be protected against hepatitis B, influenza (with annual vaccination), measles, mumps, and rubella. Where indicated because of special risk and/or exposure, meningococcal, typhoid and polio vaccination may be added as well. In general, a hospital or other health facility should monitor the immunization status of personnel and make appropriate vaccines available, according to the recommendations, said IDSA’s ACIP liaison, Samuel Katz, MD, FIDSA.
ACIP members also discussed use of the human papillomavirus (HPV) vaccine, which the committee recommended for use in males last year. ACIP’s current permissive recommendation, which stops short of calling for routine use in males, will remain in effect until more convincing data on cost effectiveness are available, according to Dr. Katz.
ACIP recommendations become official once approved by the Centers for Disease Control and Prevention (CDC) and published in MMWR.
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.
Newly revised immunization schedules for all age groups are now online at: www.cdc.gov/vaccines/recs/schedules/default.htm.
For children and adolescents, the new recommendations include booster shots for meningococcal meningitis and pertussis. Guidance has been added for the hepatitis B vaccine schedule for children who did not receive a birth dose. There is also new guidance about administration of one or two doses of seasonal influenza vaccine based upon the child's history of monovalent 2009 H1N1 vaccination. See the Feb. 11 Morbidity and Mortality Weekly Report (MMWR) for more information.
Adults are also advised to be immunized against pertussis, especially adults who are in contact with infants. The new adult schedule was published in the Feb. 4 MMWR.
IDSA resources can help physicians select an EHR system and meet requirements
During the next five years, eligible physicians can receive as much as $44,000 under Medicare or $63,750 under Medicaid for adopting certified electronic health record (EHR) technology and using it to achieve specified goals, known as “meaningful use.” Information to help ID physicians and their practices select an EHR system and qualify for these new incentives is available on IDSA’s website. (You must be logged in to access this page.)
The resources include a free online tool for physicians to evaluate and compare different applications based on criteria specific to the ID specialty, as well as links to additional resources from the American College of Physicians to help practices select health information technology tools.
Selecting an EHR system is a complex process, said Wanda Torres, director of physician billing with ID Care, a private ID practice with 29 physicians and several offices in New Jersey. The practice implemented an EHR system in 2007 after an extensive review process, including viewing demonstrations from several software vendors, visits to other practices using similar systems, and evaluating the functionality and customization options available. With an EHR system in place, the practice is now taking steps to participate in the “meaningful use” incentive program offered by the Centers for Medicare and Medicaid Services (CMS).
To qualify for the incentive payments, eligible physicians must report on six total quality measures and 20 meaningful use objectives. The quality measures include three core measures (hypertension, tobacco screening and cessation, and adult weight screening—alternates can be substituted if these don’t apply) and three additional quality measures. The meaningful use objectives include 15 core objectives (such as implementing drug-drug and drug-allergy checks or maintaining an up-to-date list of diagnoses) and five additional objectives (such as implementing drug-formulary checks or incorporating clinical lab-test results into the EHR).
Registration for the program began in January through the CMS website. Physicians who provide less than 90 percent of their services in an inpatient hospital setting or emergency room are eligible for the incentive program, a requirement that is verified during the online registration process.
To get the maximum EHR incentive payment of $44,000, Medicare eligible professionals must begin participation by 2012—providers will only have to demonstrate “meaningful use” for 90 continuous days during the first payment year while subsequent payment years will be for the entire calendar year. Payment penalties of 1-2 percent will be levied against eligible professionals who do not become “meaningful users” by 2015.
Of note, a separate CMS incentive program for electronic prescribing (eRx) also has implications for practices using an EHR system. To avoid a payment penalty in 2012, physicians must still report at least 10 electronic prescriptions on their claims during the first six months of 2011 even if they are using an EHR system with eRx functionality. IDSA has developed a schedule of incentive payments and penalties to help you better understand and compare Medicare’s various incentive payment programs.
For additional information, including a general guide from CMS, a schedule of EHR payment incentives and penalties, and a chart to assist providers in determining their eligibility, see IDSA’s website. For help with registration, an EHR Information Center Help Desk is available for questions at (888) 734-6433 from 8:30 a.m. to 4:30 p.m. on weekdays in all time zones. In addition, a free online video tutorial from CMS provides a step-by-step guide to the registration and attestation process. CMS also recently launched a listserv about the EHR incentive program to provide updates on registration, attestation, and the payment process. Click here to join the listserve.
IDSA’s practice management listserve is another resource for Society members to discuss clinical practice-related issues, including incentive programs. To subscribe, visit IDSA’s website.
Have tough coding questions? Picking the right code level can be difficult due to the complicated rules governing inpatient consultations, subsequent hospital visits, prolonged serves, and incident-to billing. If IDSA’s many coding resources aren’t enough, “Ask the Coder” can help. This online resource was developed to assist IDSA members and their office staff. If you have a question about evaluation and management (E&M) or current procedural terminology (CPT) service codes, take advantage of this member benefit by filling out the form on the “Ask the Coder” Portal, and your question will be sent to a certified professional coder for a response.
Help increase the accuracy of ID physicians’ compensation and cost data by participating in the Medical Group Management Association’s (MGMA) 2011 Physician Compensation and Production Survey. Participation in this influential survey makes a difference to your practice and to the specialty of infectious diseases. (To see results from previous years’ surveys, visit IDSA’s website (login required)).
To participate online, go to www6.mgma.com by March 11. Completing the survey is free; you do not need to be an MGMA member, but you will be prompted to create a username and password for the MGMA site.
For your participation efforts, you will also receive the following from MGMA:
If you need assistance with the survey, please contact MGMA toll-free at 877-ASK-MGMA (275-6462), ext. 1895, or by e-mail at firstname.lastname@example.org.
This week, Science Speaks, the blog of the Center for Global Health Policy, will feature a series of interviews with key players in the scale-up of medical male circumcision (MC) in several sub-Saharan African countries. In order to reduce HIV prevalence in high-burden countries with low rates of MC and a predominantly heterosexual epidemic, countries are launching accelerated saturation initiatives (ASI), which attempt to circumcise a large proportion of the male population in a short amount of time.
Medical MC provides up to 60 percent protection from HIV acquisition during vaginal sex, and mathematical modeling predicts that population-level initiatives such as these can reduce prevalence dramatically over time, with impact directly proportional to implementation pace and scale. The Center recently issued an issue brief (click here to download) discussing best practices, highlighting some of the recent successes in enhancing access to MC, and supporting the expansion of these services.
The blog series will feature updates and commentary from implementers on the ground, including those involved with the President’s Emergency Plan for AIDS Relief (PEPFAR) program, with an important update on the ambitious one-year ASI program in Swaziland, which aims to circumcise 80 percent of males ages 18 to 49 by the end of 2011. The series starts Feb. 28, so be sure to stay tuned to ScienceSpeaksBlog.org.
In a two-part series on Science Speaks, the Center for Global Health Policy recently interviewed scientific leaders at the Bill & Melinda Gates Foundation for their perspectives on key developments in HIV and tuberculosis (TB) in the last year, and what they see coming down the pipeline in the year ahead. Reporter John Donnelly spoke with Stefano Bertozzi, MD, PhD, director of the Gates HIV and tuberculosis programs, and Peter M. Small, MD, senior program officer for TB at the Gates Foundation. Drs. Bertozzi and Small discussed the rapid scale up of medical male circumcision, the Global Fund and the global financial crisis, and the promise of the Gene Xpert, a TB diagnostic machine that can detect TB and drug resistance in 90 minutes, whereas current methods can take up to three months. Check out ScienceSpeaksBlog.org for the full posts.
But cuts proposed by House lawmakers threaten public health here and abroad
President Obama’s budget for the 2012 fiscal year (FY) makes needed investments to strengthen key U.S. public health and research initiatives, in addition to strengthening the country’s capacity to prevent, diagnose, and treat an increasing number of ID threats, according to IDSA’s analysis. However, cuts proposed by the House of Representatives for the remainder of FY2011 would threaten these important gains in public health.
Released in February, the president’s budget supports critically needed ID research at the National Institutes of Health (NIH), especially at the National Institute for Allergy and Infectious Diseases (NIAID), according to an IDSA statement in response to the budget. An analysis published earlier this month in the New England Journal of Medicine underscores the important benefits this funding has on improving public health.
The president’s proposal includes investments for critical ID programs at the Centers for Disease Control and Prevention (CDC) and for the Food and Drug Administration (FDA)’s much-needed regulatory science and countermeasures initiatives. The Society also welcomed $765 million proposed for the Biomedical Advanced Research and Development Authority (BARDA), including funding to provide financial and business support to companies that develop new antibiotics and other medical countermeasures.
These critical investments in public health would be undercut by shortsighted spending cuts for the remainder of FY2011 proposed in February by lawmakers in the House.
In a joint statement, IDSA, the HIV Medicine Association (HIVMA), and the Center for Global Health Policy highlighted the danger to public health here and around the world posed by the drastic proposed cuts in critical funding for CDC, NIH, FDA, the Health Resources and Services Administration, the United States Agency for International Development, and other agencies. In an e-mail, IDSA also urged members to contact their members of Congress to communicate the value of funding ID and HIV-related research and public health programs and the dire consequences of these cuts.
For additional information about the president’s funding proposals for domestic HIV/AIDS funding and global HIV and tuberculosis, please see press releases issued by HIVMA and the Center for Global Health Policy (PDF).
As the federal government takes steps to implement the health care reform law, IDSA and its members continue to weigh in on specific provisions and how they will affect ID clinicians.
In February, the Society responded to several questions raised by the Centers for Medicare and Medicaid Services (CMS) about plans in the law to develop a system to pay physicians differentially based on the quality and cost of their care. In a letter, IDSA addressed questions posed by CMS at a September 2010 listening session about resource use reporting and value-based payments for physician services. Lawrence Martinelli, MD, FIDSA, and Steven Schmitt, MD, FIDSA, joined IDSA staff in meeting with CMS officials to discuss ID physicians’ perspectives on these provisions of the health reform law.
Drs. Martinelli and Schmitt also met with Center for Medicare and Medicaid Innovation (CMMI) officials to discuss innovative payment models that incentivize ID physicians’ infection prevention and antimicrobial stewardship activities. Earlier in February, Daniel McQuillen, MD, FIDSA, chair of IDSA's Clinical Affairs Committee, Ronald Nahass, MD, FIDSA, and IDSA staff made the same argument during a meeting with Medicare Payment Advisory Commission (MedPAC) officials.
Drs. McQuillen and Nahass also met with congressional staff to underscore the negative impact that Medicare's decision to eliminate payment for the consultation codes has had on cognitive specialties, such as infectious diseases (see related IDSA News article).
IDSA’s success depends on members who volunteer their time to serve in leadership positions. The Nominations Committee is seeking nominations for the Board of Directors. Nominations are due April 1. From members’ suggestions, the Nominations Committee will select a slate of candidates for the 2011 elections, which will take place in the summer.
The Call for Nominations for the 2011 election describes the available positions. Members can nominate themselves or colleagues.
The form can be filled out online or downloaded and e-mailed to email@example.com; faxed to 703-299-0204; or mailed to IDSA Nominations Committee, 1300 Wilson Blvd., Suite 300, Arlington, VA 22209.
Michael Horberg, MD, MAS, vice chair of the HIV Medicine Association (HIVMA), has been named executive director of research for the Mid-Atlantic Permanente Medical Group in Rockville, Md. Dr. Horberg will continue to serve as director of HIV/AIDS at Kaiser Permanente and as clinical lead for HIV/AIDS for the Care Management Institute. He is also currently a research scientist in the Division of Research at Kaiser Permanente Northern California; HIV Clinician at Kaiser Santa Clara; and chair of Kaiser Permanente Northern California’s Central Research Committee. He also serves on the IDSA Education Committee and is chair of the HIV MOC Development Committee.
Abad, Cybele, MD
Abraham, George, MD
Finelli, Lyn, DrPH
Flores-Villanueva, Pedro, MD, MS
Kubal, Mandar, MD
Lindow, Janet, PhD
Madan, Rajat, MBBS, PhD
Ng, Oon Tek, MBBS, MPH, MRCP
Olsvik, Orjan, PhD
Phillips, Michael, MD
Adler, Cheryl, BSN
Alameda, Jeannine, MBA
Bauer, Karri, PharmD
Chalkias, Spyridon, MD
Chhasatia, Praful, MD
Godin, Jamie, PharmD
Hudson, Justin, DPM
Lathrop, Virginia, MS
McCraw, Ronald, DO, MA, PhD
Nguyen, Phuongthao, PharmD
Portegies, Peter, MD
Sharief, Mohammad, MD
Sharma, Abhineet, BCh
Sharma, Anuradha, MD, MBBS
Sherer, Travis, PA-C
Sidorenko, Sergey, DMsc
Thompson, Jan, MS,PA-C,PhD
Barbour, Sarah, MD
Goad, John, DO
Govindaraju, Raghavendra, MD
Griffith, Milena, PharmD
Patel, Parag, MD
Rivera, Rachel, MD
Root, Andrew, MD
Dorman, Nancy, MD, PhD
Karakusis, Peter, MD
IDSA members can register for free to view sessions from IDSA’s Seasonal and Pandemic Influenza 2011 conference online. Sessions from the conference, which took place Jan. 27-28, are available to view on-demand, with CME credit available.
This year’s program featured an array of topics including epidemiology, cross-cutting issues like communication, antiviral deployment, and infrastructure and surge. Speakers addressed:
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.
For more information, visit www.idsalive.com.
IDSA, in partnership with the Society for Healthcare Epidemiology of America (SHEA), the Centers for Disease Control and Prevention (CDC), and Medscape, is offering a free CME activity, “Antimicrobial Resistance Across the Continuum of Care: Winning the War One Battle at a Time.” The activity includes a roundtable discussion with antimicrobial resistance and stewardship experts and is intended for clinicians who regularly prescribe antibiotics.
Improving antibiotic use in this country is imperative. The goal of this activity is to raise awareness of the potential public health crisis created by inappropriate antibiotic prescribing and antibiotic resistance in the United States in an effort to motivate clinicians to change the prescribing practices that created the problem. At the completion of the 45-minute program, clinicians should be able to:
To participate in this free CME activity, please visit http://www.medscape.org/viewprogram/31864.
Oxford University Press began publishing Clinical Infectious Diseases and The Journal of Infectious Diseases in January 2011.
If you would like to receive electronic table of contents (eTOC) and advanced access alerts, you’ll need to sign up with an Oxford University Press My Account. To do so, please follow these steps:
Your account will now be set up; all you have to do is visit the Alerts Preferences page and select the journal(s) you would like to receive alerts from.
If you experience any difficulties creating a new account or accessing any of the content, contact Oxford University Press.
We can all recall the invaluable guidance and support we received from mentors and others early in our careers. Investing in young physicians and investigators is a great way to provide vital support to those who are the future of our field. IDSA pursues this important goal in many ways.
We can all recall the invaluable guidance and support we received from mentors and others early in our careers. Investing in young physicians and investigators is a great way to provide vital support to those who are the future of our field.
Since 2002, more than 260 medical students have received scholarships through IDSA’s highly successful Medical Scholars Program, which provides mentorship by an IDSA member or fellow. This past fall, nearly 300 promising researchers from the U.S. and around the world were awarded travel grants enabling them to attend the IDSA Annual Meeting in Vancouver. These are just two examples of how IDSA is working to nurture the next generation of infectious disease physicians and scientists, an important part of the Society’s mission.
Another of the many ways IDSA pursues this goal is through the Joint Research Awards, offered by the IDSA Education and Research Foundation (ERF) and the National Foundation for Infectious Diseases (NFID). These awards support needed research by young researchers who may not otherwise find funding. The application deadline for the 2011 awards, March 15, is fast approaching. See IDSA’s website for details, including information about a new Postdoctoral Fellowship in Transplant ID.
Additional career development and funding opportunities are available for students and fellows. Another helpful resource, the ID/HIV Career Center—the official online job bank of IDSA and the HIV Medicine Association (HIVMA)—allows job seekers to look for hundreds of positions in ID and HIV medicine, register for job alert e-mails, and access career advice.
IDSA’s Annual Meeting provides valuable opportunities to highlight young investigators’ research findings, such as the Poster Discussion Rounds, travel grants, and a plenary lecture for one especially promising researcher (see the Call for Abstracts for more details).
The Annual Fellows’ Meeting, held each spring, offers an intimate and informal opportunity for fellows to learn practical clinical practice strategies from an extraordinary group of practice-based ID physicians. Marvin Tenenbaum, MD, FIDSA, and IDSA President-Elect Thomas Slama, MD, FIDSA, are organizing this year’s fellows’ meeting, which promises to provide a stimulating and timely program. Two premeeting sessions at the IDSA Annual Meeting will also highlight issues and timely topics relevant to fellows—the Fellows Day Workshop, organized by IDSA’s Training Program Directors Committee, chaired by Daniel Havlichek, MD, FIDSA, and Pediatric Fellows’ Day, co-organized by the Pediatric Infectious Diseases Society and IDSA, focusing on the pediatric ID subspecialty issues.
In February, fellows across the United States and at sites in 10 other countries participated in the 4th Annual Fellows’ In-Training Exam. Developed by IDSA’s Test Material Development Committee, chaired by Cary Engleberg, MD, FIDSA, in cooperation with the National Board of Medical Examiners, the exam assists fellowship programs in meeting new competency requirements and has been very well received.
An updated version of the popular online infection control fellows course—adapted from a course offered by Johns Hopkins University under the leadership of Trish M. Perl, MD, MSc, FIDSA, and developed in conjunction with the Society for Healthcare Epidemiology of America—is another example. Designed to give ID fellows and others basic training in infection control and hospital epidemiology, at their own pace and without having to travel, the course satisfies the Accreditation Council for Graduate Medical Education requirement for training in hospital epidemiology. The course is available online at www.iccourse.org.
In closing, I would like to call your attention to several other high-priority activities. Articles in this month’s issue of IDSA News provide additional details:
Be sure to mark your calendar for World Health Day, April 7, which is organized by the World Health Organization and this year will focus on raising global awareness about antimicrobial resistance. IDSA plans to mark the day with a press event in Washington, D.C., highlighting the problem and emphasizing the urgency of addressing this public health threat. Details will be available on the website closer to the event.
Developed by IDSA and the European Society for Clinical Microbiology and Infectious Diseases (ESCMID), an updated guideline for the treatment of acute uncomplicated cystitis and pyelonephritis in women is now available online.
An updated guideline for the treatment of acute uncomplicated cystitis and pyelonephritis in women is now available online. Developed by IDSA and the European Society for Clinical Microbiology and Infectious Diseases (ESCMID), and previously updated in 1999, the guideline appears in the March 1 issue of Clinical Infectious Diseases.
The guideline reflects several changes since 1999 affecting management of these infections, such as an increase in antimicrobial resistance among uropathogens, an appreciation of the ecological adverse effects of antimicrobial therapy (collateral damage), and a focus on clinical outcomes.
Recommendations give clinicians direction regarding the optimal treatment in adult non-pregnant, premenopausal women. Specifically, the guideline presents doses and durations of different treatment regimens in the context of changing resistance rates. In addition, better estimations of response rates for women resistant to drug treatment are discussed.
The 2010 guideline also has an international focus and incorporates drugs that are not uniformly available or familiar to U.S.-based clinicians, such as pivmecillinam and fosfomycin. The main message of the guideline is that no single agent is the optimal choice for management of uncomplicated urinary tract infections, and local resistance patterns, drug availability, expected efficacy, and individual patient characteristics all need to be taken into consideration on a case by case basis.
“The treatment algorithm is less of a cookbook approach and more of a decision-making process that hopefully will be incorporated into everyday practice,” said Kalpana Gupta, MD, lead author of the guideline and chief of the Section of Infectious Diseases at VA Boston Health Care System. “No single drug will be the right answer for every patient every time.”
The guideline notes several areas of research regarding the treatment of uncomplicated cystitis that will require further investigation. Future updates should address a better understanding of collateral damage from short course cystitis regimens, the public health impact of antimicrobial use and resistance in women, and the efficacy of short course (7-10 day) regimens with trimethoprim-sulfamethoxazole for pyelonephritis.
Several key performance measures identified in the guideline include:
Available online, this guideline is dedicated to the memory of Walter E. Stamm, MD, FIDSA, whose work and commitment over several decades enhanced the understanding of the pathogenesis, epidemiology, and management of urinary tract infections in women.
Other IDSA guidelines are available on the Standards, Practice Guidelines, and Statements page of our website.
This month, studies investigating: fidaxomicin for the treatment of Clostridium difficile infection; nontuberculous mycobacterial cervicofacial lymphadenitis in children; the benefits of human papillomavirus (HPV) vaccination in males; and stem cell transplantation as an HIV “cure.”
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.
Recent observations have noted reduced clinical response rates and increased recurrence rates in patients with Clostridium difficile infection (CDI). These findings have prompted a search for more efficacious treatment regimens. A phase III trial published in the Feb. 3 issue of The New England Journal of Medicine examined the potential role of fidaxomicin in treating adults with CDI.
Fidaxomicin is a recently discovered macrocylic antibiotic with limited in vitro activity against normal gut flora, greater in vitro activity than vancomycin against C. difficile, minimal systemic absorption, and no cross-resistance with other antibiotic classes. This agent is also bactericidal against C. difficile, while vancomycin is bacteriostatic.
To further evaluate this compound, the authors performed a prospective, double-blind, randomized trial comparing fidaxomicin (200 mg orally every 12 hours) to vancomycin (125 mg orally every six hours) in the treatment of a first or second episode of CDI. The clinical cure rate was not significantly different between treatment groups. However, CDI recurrence rates were significantly fewer in the group treated with fidaxomicin in both the modified intention-to-treat analysis (P=0.005) and the per-protocol analysis (P=0.004). Global cure rates (clinical cure and lack of relapse) were also found to significantly favor the fidaxomicin treatment group (P=0.006). Adverse events were similar between treatment groups as well, and no patients discontinued the study due to intolerance or side effects.
Although both medications exhibited similar efficacy in respect to clinical resolution, the authors observed a more sustained, durable response in the group treated with fidaxomicin. The additional benefit of decreasing overall vancomycin use and the subsequent development of vancomycin-resistant enterococcus suggest this agent will be a welcome addition in the treatment of such a difficult pathogen.
A conservative “wait and see” approach resulted in similar healing times compared to combination antibiotic therapy among children with advanced nontuberculous mycobacterial (NTM) cervicofacial lymphadenitis. Published in the Jan. 15 issue of Clinical Infectious Diseases, the findings are from a randomized non-inferiority study conducted in the Netherlands.
Immunocompetent children with microbiologically-proven advanced NTM cervical lymphadenitis characterized by fluctuation of the lymph node and discoloration of the skin were randomized to receive either clarithromycin plus rifabutin for 12 weeks or no pharmacologic intervention. The primary outcome was regression of lymph node enlargement by 75 percent with cured fistula and total skin healing. The secondary outcome was medication adverse events.
The study included 50 children with a median age of 35 months and an NTM infection lasting approximately nine weeks. The majority were infected with M. avium (70 percent) and M. hemophilum (24 percent). Median times to resolution of lymphadenitis were 36 weeks for the treatment group and 40 weeks for the non-intervention group (p=0.4). No recurrences were noted in either group after two years of follow-up. The most common adverse events in the treatment group included abdominal pain (28 percent) and extrinsic tooth discoloration (64 percent).
Most children with early NTM cervical infections undergo surgery, which is curative. This study confirms case reports and case series that suggest that withholding antibiotic treatment of advanced NTM cervical infections in children is reasonable. One major limitation is the sample size of the study, which may not have detected small, but clinically meaningful differences in healing times.
Human papillomavirus (HPV) causes genital infection in both sexes. A quadrivalent HPV vaccine provided protection against HPV infection and HPV-related disease in males in a study published in the Feb. 3 edition of The New England Journal of Medicine.
In a placebo-controlled, double-blind study, 4,065 males 16 to 25 years old were randomized to receive three doses of quadrivalent vaccine (active against HPV-6, 11, 16, and 18) or placebo. Vaccination had an overall efficacy of 60.2 percent in preventing external genital lesions, although predominantly condyloma accuminata and not penile, perianal, or perineal intraepithelial neoplasia. Efficacy was 65.5 percent when the lesions were associated with HPV-6, 11, 16, or 18. When individual HPV types were considered, significant reductions were seen only in lesions associated with HPV-6 and HPV-11. Vaccination had an efficacy of 47.8 percent in reducing the incidence of persistent infection (detection of the same HPV type in an anogenital swab or biopsy specimen over at least six months).
Vaccination was also effective in reducing the detection of HPV DNA of any type at any time. Improved vaccine efficacy was observed in a per-protocol population that was initially seronegative and DNA negative and received all vaccinations within one year.
The results suggest that quadrivalent HPV vaccination protects against infection and some forms of HPV-associated genital disease in males, although effects on other relevant outcomes, such as anogenital and oropharyngeal cancer or respiratory papillomatosis, were not reported. Indirect effects of HPV vaccination of males on preventing HPV transmission to sexual partners were also not assessed. Ultimately, additional data demonstrating the efficacy of vaccination in protecting against multiple forms of HPV-associated disease in males and in preventing transmission to sexual partners will likely be needed to support the cost effectiveness of universal HPV vaccination in both sexes.
In Germany in 2007, a patient with HIV and acute myeloid leukemia (AML) received a stem cell transplant (SCT) with donor cells that were homozygous for the HIV-resistance gene (the CCR5-delta32 deletion). The case garnered significant attention at the time because of the potential for this transplant to eradicate HIV in the patient while also treating the AML.
More than three years later, an update on this pioneering case published in the Jan. 14 issue of AIDS states that the patient remains off of antiretroviral therapy with no evidence of active HIV replication. In addition, the patient’s CD4 cell count now exceeds 800/µL. Investigation of cells derived from the transplant, including gut macrophages, has shown these cells to all be CCR5 negative, suggesting that all infectable target cells and reservoirs have been replaced with CCR5-negative cells. This evidence supports the notion that the patient is now cured of HIV.
The case provides an exciting proof of principle. However, the authors have been unable to repeat their findings in a second patient. Despite an international search over a three-year period, the authors have been unable to identify any additional HIV-infected patients who are both eligible for transplant and have a HLA-matched donor who is homozygous for the CCR5-deletion. This failure underscores that the chance to perform such transplants will be exceedingly rare going forward, and thus, the relevance of this strategy to treat HIV remains in question. Still, the authors argue that the successful outcome in their patient suggests that at the very least, gene therapy for HIV is worth exploring further.