IDSA News - June 2012
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ACIP Adjusts Influenza Vaccine Dosing for Young Children

The federal Advisory Committee on Immunization Practices (ACIP) recently updated its recommendation on the number of vaccine doses young children should receive during the upcoming influenza season.

Children ages 6 months through 8 years will require two doses of vaccine this season if they have not been previously vaccinated with at least one vaccine dose containing the 2009 A H1N1 strain, which was included in the 2009 monovalent influenza vaccine and in the 2010-2012 seasonal vaccine, according to Jeffrey S. Duchin, MD, FIDSA, who attended the June 20-21 ACIP meeting. The approach is already supported by the American Academy of Pediatrics. ACIP members also heard updates on vaccine effectiveness and safety during the previous influenza season. For a summary, see CIDRAP News.

In addition, the committee voted to recommend a combination regimen of pneumococcal polysaccharide vaccine and the 13-valent pneumococcal conjugate vaccine for immunocompromised adults. The recommendation may present some challenges in communication to providers and in implementation, given variations that depend upon whether an adult is naïve to pneumococcal vaccination or has previously received polysaccharide vaccine, as well as timing issues, noted William Schaffner, MD, FIDSA, who also attended the meeting.

Committee members also discussed safety and efficacy data for the human papillomavirus vaccine, protections against hepatitis B among health care workers, a new combination meningococcal vaccine recently licensed in the U.S., post-exposure prophylaxis for measles with immune globulin, and the current poor state of adult vaccination coverage in the U.S.

ACIP recommendations become official once approved by the Centers for Disease Control and Prevention (CDC) and published in the MMWR. Meeting presentations will be available shortly on CDC’s website: www.cdc.gov/vaccines/recs/ACIP/.

CDC Updates Recommendations for Carbapenem-Resistant Enterobacteriaceae

Last week, the Centers for Disease Control and Prevention (CDC) issued updated recommendations for how states, health care facilities, clinicians, and patients should deal with carbapenem-resistant Enterobacteriaceae (CRE), which are resistant to almost all drugs, have the potential to spread rapidly, and can contribute to death in 40 percent of patients who become infected.

The updated materials include:

  • New CRE toolkit: Provides updated guidance to health care facilities and state health departments about preventing the spread of CRE. The toolkit is also available as a PDF.
  • New CRE website: Includes resources for clinicians, health care facilities, states, and patients.
  • MMWR article: Provides a case report of CRE containing the New Delhi metallo-beta-lactamase (NDM) enzyme. 
  • State prevention stories from Wisconsin and Minnesota

New Guideline Pocketcards: Rhinosinusitis and Diabetic Foot Infection

Practice guidelines developed by IDSA on the diagnosis, prevention, and treatment of rhinosinusitis and diabetic foot infections are now available as Pocketcards. IDSA members are eligible for a 35 percent discount when ordering these 4x7-inch quick-reference tools that feature essential diagnostic and treatment recommendations in a brief format. Use discount code DCIDSA12.

Don’t forget about guidelines in a format designed for iPhones and other mobile devices. Visit IDSA’s website for instructions for downloading and using guidelines on your mobile devices.

IDSA Weighs In on CMS Inpatient Proposed Rule

The Society recently weighed in on the Centers for Medicare and Medicaid Services’ (CMS) proposed changes to the Inpatient Prospective Payment System rule for the 2013 fiscal year. IDSA’s comments focused on the Value-Based Purchasing Program, the Inpatient Quality Reporting Program, and the Hospital-Acquired Condition Payment Policy. To read the full comments, see IDSA’s website (PDF).

“Cured” HIV Patient, Researchers Discuss AIDS Fight

Timothy Brown, the so-called Berlin patient, who received a bone marrow transplant from a donor with natural resistance to HIV to treat his leukemia and was consequently cured of his HIV infection, shared his story at a recent Washington, D.C., briefing  that also featured panel discussions on recent work towards an HIV cure and policy implications. Read more on Science Speaks, the blog of the Center for Global Health Policy.

More recent news from the blog:

WHO: Pregnant Women with HIV Should Have Access to Optimal Drug

A recent update from the World Health Organization recommends that one of the most effective antiretroviral treatments, efavirenz, be given to pregnant women with HIV, in light of evidence showing that it is safer than previously thought. Science Speaks, the blog of the Center for Global Health Policy, has more.

More recent news from the blog:

TB Treatment Trial Raises Hopes

Researchers who tested the safety and effectiveness of a new approach to tuberculosis treatment in recent global clinical trials are saying the results offer hope that a drug that could shorten the period during which patients can spread the disease to others, while addressing multi-drug-resistant infections. Check out Science Speaks, the blog of the Center for Global Health Policy, for more details.

More recent news from the blog:

IDSA Supports Universal Vaccination Through State Mandates

As lawmakers in California and other states consider bills related to exemptions from state immunization requirements, IDSA has developed a new policy statement (PDF) to provide  stakeholders working on this issue with a tool to advocate for universal immunization coverage.

IDSA supports universal immunization of children, adolescents, and adults, except when medically contraindicated. Substantial scientific evidence demonstrates the safety and effectiveness of vaccines and their enormous value in protecting individuals, the public health, and vulnerable populations from serious and life-threatening infections. Maintaining high immunization rates is critical for protecting people who are not able to be immunized, such as infants too young to be vaccinated, people with HIV or cancer, and other immunocompromised individuals.

To promote universal access to all recommended immunizations, IDSA recommends that states remove financial and other barriers to immunization; ensure that scientifically accurate, lay-friendly information on vaccines and vaccine-preventable diseases is readily available; and ensure that immunization mandates are uniformly implemented.

IDSA urges states to eliminate non-medical exemptions from vaccine requirements. States that are unable to do so should adopt safeguards to protect the public health, including tracking exemption rates and assessing the impact they may have on disease rates, ensuring that all state-granted exemptions are reviewed annually, and requiring individuals seeking belief-based exemptions (in states that choose to permit them) to take certain steps.

IDSA’s full policy statement is available online. See IDSA’s website for additional Society policy statements related to mandatory influenza immunization for health care workers and adult and adolescent immunization coverage.

IDSA Leads Support for Increased BARDA Funding

The Society led a group of 36 organizations and companies earlier this month in urging Congress to increase funding for the Biomedical Advanced Research and Development Authority (BARDA), which invests in medical countermeasures research and development. BARDA funding helps support development of next-generation influenza vaccines, new diagnostic platforms, broad-spectrum antimicrobials, various antivirals, and countermeasures for radiological and chemical weapons.

The letter was co-authored by the Biotechnology Industry Organization, the Center for Biosecurity of the University of Pittsburgh Medical Center, and Trust for America's Health. Read the full letter online (PDF).

IDSA Supports Age-Based HCV Screening Guidelines

In a recent letter, IDSA supported new age-based hepatitis C virus (HCV) screening guidelines proposed by the Centers for Disease Control and Prevention and urged their timely implementation. The recommendation of a one-time screening for all Americans born during the period 1945 to 1965 is warranted, IDSA noted, as this patient population accounts for more than 85 percent of all Americans infected with chronic HCV. The letter is available online (PDF).

Society Comments on Federal Action Plan to Prevent HAIs

IDSA commented on the revised National Action Plan to Prevent Healthcare-Associated Infections (HAIs), including recommendations regarding antimicrobial stewardship, expansion of the action plan beyond acute care hospitals, and goals for influenza and hepatitis B vaccination rates and screening rates for hepatitis C. The plan is being developed by the Department of Health and Human Services. IDSA’s full comments are online. (PDF)

Check Out “My IDSA” for Latest Member News

Find the latest membership news on “My IDSA” on the IDSA website, including new IDSA members; updates on Ardis Dee Hoven, MD, Thomas M. File, Jr., MD, FIDSA, and Edward J.Septimus, MD, FIDSA; and a remembrance of Emanuel Wolinsky, MD.

Are you a member on the move? Do you know someone who is? Contact Stephanie Cox at scox@idsociety.org so that we can announce it to our membership.

Clinical Microbiology Learning Tool Available Online

A set of clinical microbiology vignettes—cases or laboratory scenarios that use an interactive, quiz-based tool for self learning—are available online through the Department of Pathology and Laboratory Medicine at Emory University School of Medicine. The username and password for the site are the same: MicroV

Used by Emory medical students, MPH students, pharmacy students, pathology residents, internal medicine residents, ID fellows, and faculty, the tool may be useful for ID fellows who are studying for board exams and for members who want to recertify.

The vignettes are sorted by microbiology, clinical, and public health topics, and are formatted as quizzes that give feedback after each question is answered. After resolving each case or scenario, you will be able to:

  • Identify the tests that are useful for the diagnosis.
  • Distinguish microbiological and morphological characteristics of the organism.
  • Recognize clinical and pathological characteristics caused by these agents.
  • Outline basic principles of treatment and prevention.
  • Explain public health implications of the agents presented.

How to Manage Information Overload

Are you struggling to keep up with the information overload in infectious diseases? IDSA offers several services to help time-strapped ID professionals keep up to date in a concise manner:

ID News Clips

This daily free news clipping service is provided to keep you apprised of information about infectious diseases that is available on the Internet. Subscribers receive a daily e-mail with ID headlines from the lay press, with links to full-text articles on external websites. This service helps you keep up with the information your patients and the public are reading.

CDC Health Alert Network Service

This service forwards Health Alert Network messages from the Centers for Disease Control and Prevention (CDC) about outbreaks, bioemergencies, and other timely events. It is intended for members who do not receive these messages from other sources.

FDA Alert Forwarding Service

This service forwards ID-related messages from the Food and Drug Administration (FDA) and other sources on label changes, adverse events, newly approved drugs, and other safety information on FDA-approved drugs and biologics.

All these services are provided to you as an IDSA member at no charge. To subscribe, simply click here. (Log-in required).

By subscribing, you agree to receive e-mail messages from IDSA. You can unsubscribe at any time.

Congress Passes Antibiotic Incentives Legislation

AMA also voices support for developing needed antibiotics, stewardship programs

Earlier this week, lawmakers took a critical step in addressing antibiotic resistance by passing legislation with provisions to address the lack of new antibiotics in development.

Earlier this week, Congress took a critical step in addressing antibiotic resistance by passing legislation with provisions to address the lack of new antibiotics in development. The Food and Drug Administration (FDA) Safety and Innovation Act provides much-needed incentives to spur renewed interest in antibiotic research and development (R&D) and also calls for a review of antimicrobial stewardship programs as a critical tool for protecting the effectiveness of current antibiotics. In a statement, IDSA President Thomas G. Slama, MD, FIDSA, commended Congress’ action.

While the bill is a critical step in the right direction, more work will be needed to ensure new antibiotics come to market, as outlined in IDSA’s 10 x ‘20 Initiative. IDSA will continue to work with the other endorsers of the initiative to advocate for:

In addition to Congress, the American Medical Association’s (AMA) House of Delegates (HOD) recently voiced support for the development of critically needed new antibiotics as well as antimicrobial stewardship programs to preserve  antibiotics’ effectiveness. Earlier this month, the HOD passed IDSA-led resolutions recognizing that “the LPAD mechanism is an extremely promising potential tool for bringing high priority antibiotics to market” and acknowledging the importance of antimicrobial stewardship along with infection control programs “as critical components of assuring safe patient care.”

To see PDFs of the full AMA resolutions, go to:

For more information about IDSA’s efforts to address the dry antibiotic development pipeline and how IDSA members can help, visit www.idsociety.org/10x20.

Supreme Court Upholds Health Care Reform Law

The Supreme Court has largely upheld the Affordable Care Act, the health reform law passed by Congress in 2010, which also contains important measures related to prevention and wellness, such as the Prevention and Public Health Fund, and requires private insurers to cover all recommended vaccines.

The Supreme Court has largely upheld the Affordable Care Act, the health reform law passed by Congress in 2010, preserving the individual mandate requiring that most Americans obtain health insurance but limiting the law’s Medicaid expansion provision.

The law also contains important measures related to prevention and wellness, such as the Prevention and Public Health Fund, a critical source of investment in public health activities. States are already using the fund to build epidemiology and laboratory capacity to track and respond to disease outbreaks; train the nation’s public health workforce; prevent the spread of HIV/AIDS and viral hepatitis; and reduce health care-associated infections. The law also requires that private insurers cover all vaccines recommended by the federal Advisory Committee on Immunization Practices with no co-payments or other cost-sharing requirements.

IDSA will continue to monitor the implementation of the law and the impact of the court’s decision, including how they will affect ID clinicians, patients, and IDSA’s priorities.

In a statement, HIV Medicine Association Chair Judith A. Aberg, MD, FIDSA, described the Supreme Court’s decision as a “significant victory for people with HIV infection” and the nation’s public health. The law is critical to improving access to HIV care by creating a level playing field for people living with HIV and others with serious and chronic conditions by expanding Medicaid to all low income individuals and creating regulated state-based exchanges for purchasing insurance. See HIVMA enews for more information about the decision and its impact on access to HIV care.

With the constitutionality of the Affordable Care Act now decided, IDSA will urge Congress to turn its attention to other important, high-priority health care issues, such as reforming the flawed Medicare physician payment formula and preventing an 8.4 percent, across-the-board cut in funding for federal health agencies scheduled to take effect in January 2013.

EIN Update: CDC Encourages Submission of Suspected C. gattii Isolates

Cases of Cryptococcus gattii outside the Pacific Northwest sparked a recent discussion among EIN members and a reminder that the Centers for Disease Control and Prevention (CDC) encourages the submission of suspected isolates.

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 EIN. The reader assumes all risks in using this information.

Cases of Cryptococcus gattii outside the Pacific Northwest sparked a recent discussion among EIN members and a reminder that the Centers for Disease Control and Prevention (CDC) encourages the submission of isolates suspected to be C. gattii for identification.

A member in Florida described a patient who had never left Florida with disseminated C. gattii infection, confirmed by an outside reference lab by phenotypic methods. “He presented with pathologic fracture of the femur with soft tissue mass status post surgery with positive culture, and subsequent lumbar puncture demonstrated cerebrospinal fluid (CSF) loaded with Cryptococcus,” the member wrote. “The serum and CSF Cryptococcal Ag was 1:4096. Is this possibly the first case acquired outside of the northwest within the continental U.S.?”


Several respondents noted cases in other parts of the country, in patients with no contact with the Pacific Northwest, including in Los Angeles and Southern California, New York state, Florida, and Michigan. CDC subsequently confirmed the isolate and provided a genotype to the clinician.

A member in Maryland cited a Dec. 15, 2011, article and related editorial in Clinical Infectious Diseases. “There appear to be two things going on,” the member wrote: “1) True emergence of an outbreak in the Pacific Northwest caused by strains of the VGII type (a-c), and 2) Increased recognition of C. gattii disease in non-Pacific Northwest states, caused by multiple different molecular types (e.g., VGI in Hawaii, VGIII in S. California and other southwest states, and scattered cases of other VGI types in other states—Michigan, Rhode Island, and Georgia).”


The member added that there appear to be “‘hot spots’ of activity in specific regions,  especially in an area in Georgia, with multiple cases recently recognized, VGI types,” and recommended that an isolate from the original commenter’s patient be sent to CDC for typing—“my bet is that it’s going to be VGI. I actually think that these cases have been there for a while; we just haven’t been recognizing them to species level.”

Management of these cases “can be very different compared to neoformans, with some fluconazole resistance, especially in VGII isolates (with bad outcomes), and lots of inflammatory disease requiring shunting, steroids, etc.,” the member wrote.


A respondent from the CDC noted that although most C. gattii cases reported to CDC were initially from Pacific Northwest states, “and involved C. gattii strains specific to the outbreak (‘outbreak strains’ VGIIa, VGIIb, and VGIIc),” the interest generated from the outbreak led clinicians elsewhere to begin reporting cases, including many locally acquired C. gattii infections in other areas.

“To date, all except one of these infections have been caused by C. gattii strains different from the outbreak strains (mostly VGI and VGIII, or ‘non-outbreak strains’),” the CDC respondent continued, usually with quite different clinical presentation: “Namely, non-outbreak strain infections appear to more often cause severe meningitis in otherwise apparently healthy adults, whereas outbreak strain infections generally cause respiratory disease in persons with underlying diseases or conditions. The optimal clinical management may also differ.”



Some laboratories distinguish isolates of C. gattii from the related species C. neoformans, but many report all cryptococcal isolates as C. neoformans,” the CDC respondent wrote. “Additionally, antigen tests can’t distinguish C. gattii from C. neoformans,” suggesting  that “many C. gattii infections are likely misdiagnosed, with the treating clinician never realizing that their patient is infected with C. gattii.” (See related EIN Update from May 2012.)

 “CDC accepts isolates suspected to be C. gattii (Cryptococcus spp from HIV-uninfected persons) for molecular identification, and encourages their submission,” the respondent wrote. “We will provide timely feedback to the treating clinician.”


Isolates can be submitted to:


Shawn Lockhart, PhD, Team Lead
CDC

1600 Clifton Rd. NE

Attn: C. gattii surveillance

DASH Unit 40

Atlanta, GA 30333



Clinicians with questions can also contact Julie R. Harris, PhD, MPH, an epidemiologist in CDC’s Mycotic Diseases Branch, at ggt5@cdc.gov.

E-mail the Emerging Infections Network.

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.

IDSA Journal Club

June 2012

This month, studies investigating: reductions in hospital stays and adverse events in community-acquired pneumonia via a simple intervention; drotrecogin alfa for severe sepsis; high-dose, extended-interval colistin dosing; and azithromycin and risk of cardiac death.

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.

Reduction in Hospital Stay and Adverse Events in Community-Acquired Pneumonia via a Simple Intervention
Reviewed by Christopher J. Graber, MD, MPH

A recent article published online in Archives of Internal Medicine describes a randomized controlled trial in which a three-step intervention for patients hospitalized with community-acquired pneumonia reduced hospital stay and medication-related adverse events without an effect on readmission rates and patient satisfaction.

The investigators randomized 401 adults admitted to two hospitals (one 900-bed university public hospital and one 300-bed private hospital) in Barcelona, Spain, to either receive usual care or to have their treating physicians follow a three-step critical pathway consisting of early mobilization, use of objective criteria for switching to oral antibiotic therapy, and use of predefined criteria for hospital discharge. A printed checklist detailing this pathway was placed in the charts of patients assigned to the intervention arm, and each participating attending physician was only assigned patients from a single arm of the study. Patients were seen daily by their attending physicians and by study investigators.

Patients in the intervention arm had a median length of stay of 3.9 days, versus 6.0 days in the usual care arm (p<.001); a similar decrease in duration of intravenous antibiotic therapy was also observed (2 versus 4 days, p<.001). Medication-related adverse events were also less frequently seen in the intervention arm (4.5 percent vs. 15.9 percent, p<.001). Readmission within 30 days and patient satisfaction were similar in the two groups. The overall case-fatality rate within 30 days of admission was low in both groups (2 percent in the intervention arm vs. 1 percent in the control arm).

While the daily presence of study investigators may have influenced the high level of compliance likely achieved in this study (as evidenced by the authors’ report that only 8 of 200 patients in the intervention arm did not receive early mobilization), this study shows that adherence to simple evidence-based guidelines can result in dramatic improvements in efficiency of care.

(Carratala et al. Arch Intern Med 2012; doi:10.1001/archinternmed.2012.1690.)

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Trial Closes Book on Drotrecogin Alfa for Severe Sepsis
Reviewed by Ed Dominguez, MD

In 2001, drotrecogin alfa (activated) (DrotAA) was approved for treatment in patients with severe sepsis. Thus began an 11-year journey from guarded optimism to growing skepticism regarding the role of this agent, culminating in 2008 with the start of Prospective Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS-SHOCK), a trial designed to re-evaluate DrottAA’s role in treating severe sepsis. An article in the May 31, 2012 issue of the New England Journal of Medicine reports the results of this trial.

PROWESS-SHOCK was a randomized, double-blind, placebo-controlled, multicenter trial in adults with infection, systemic inflammation, and shock. Patients were randomized to receive either DrotAA or placebo for 96 hours. The primary outcome was 28-day all-cause mortality. Of the 27,816 patients screened, 1,697 were recruited and 1,680 were evaluable (846 in the DrottAA arm and 834 in the placebo arm). Baseline clinical characteristics were similar although DrottAA patients were more likely to have an identified organism (73.2 percent vs. 68.0 percent, P=0.02). The lungs were the most common primary site of infection followed by the abdomen and the urinary tract.

At day 28, all-cause mortality was 26.4 percent in the DrottAA arm and 24.2 percent in the placebo arm. In patients with severe protein C deficiency at the outset, mortality was slightly higher in the placebo group, 28.7 percent v 30.8 percent. By day 90, mortality had climbed to 34.1 percent and 32.7 percent, respectively. None of the differences reached statistical significance. As expected, bleeding was more often encountered in the DrottAA recipients.

An accompanying editorial notes that the study did not achieve statistical power as hoped. Nonetheless, the design was precise in its clinical definitions, effective at blinding, and successful in randomization. The editorial authors remark that the journey is now over for DrottAA after this study, and now we wait for another sepsis drug to embark on a new journey.

(Ranieri et al. N Engl J Med. 2012; 366:2055-2064.)

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Is High-Dose, Extended-Interval Colistin Dosing Safe and Effective?

Reviewed by Shireesha Dhanireddy, MD

Colistin has been used to treat severe multidrug-resistant (MDR) Gram-negative infections, but efficacy widely varies, possibly due to suboptimal dosing regimens, as colistin exhibits concentration-dependent bactericidal activity. In the June 15 issue of Clinical Infectious Diseases, the authors of a study argue that current dosing regimens lead to subtherapeutic peak concentrations and prolonged time to steady state.

The researchers conducted a prospective, observational, cohort study to assess the efficacy and toxicity of a high-dose and extended-interval dosing regimen of colistin in critically ill patients with colistin-sensitive MDR Gram-negative bloodstream infections or ventilator-associated pneumonia. Patients received a loading dose of colistin 9 million units (MU) followed by 4.5 MU every 12 hours for maintenance. Doses were adjusted for impaired creatinine clearance. A total of 28 patients were prescribed colistin but three were excluded as they were either discharged or died within 72 hours of treatment. Three patients developed infections with another pathogen and were included for each infection. Acinetobacter baumannii and Klebsiella pneumoniae accounted for the majority of infections, 46.4 percent for each, and Pseudomonas aeruginosa (7.2 percent) for the remainder.

Half of patients received colistin as monotherapy, and the other half received it either in combination with either an aminoglycoside or a carbapenem. Serum concentrations of colistin were not measured. Eighty-two percent of patients achieved clinical cure. Acute kidney injury occurred in 5/28 of the treatment courses, with increases in creatinine from normal baseline to 2.09-5.85 mg/dL, which occurred within two to five days of therapy. Renal function improved by 10 days of discontinuation of therapy in all patients. Renal toxicity that did occur was not associated with duration of treatment or cumulative doses of colistin.

The study authors conclude that high-dose, extended interval dosing of colistin is effective without leading to significant renal toxicity in critically ill patients with serious MDR Gram-negative infections. A larger, multicenter study is needed to confirm these findings.

(Dalfino et al. Clin Infect Dis. 2012;54:1720-6.)

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Azithromycin and Risk of Cardiac Death: Another Reason to Curb Unnecessary Antibiotic Use
Reviewed by Rachel Simmons, MD

A study in the May 17 issue of theNew England Journal of Medicine should lend more weight to public health campaigns to curb the use of unnecessary antibiotics.

Researchers used data from Tennessee Medicaid enrollees to estimate the risk of cardiovascular death during a five-day day course of azithromycin compared to no antibiotics and compared to a course of amoxicillin, ciprofloxacin, or levofloxacin. The study included 347,795 prescriptions for azithromycin, 1,391,180 non-prescription periods, 1,348,672 prescriptions for amoxicillin, 264,626 prescriptions for ciprofloxacin, and 193,906 prescriptions for levofloxacin. The most common indications for azithromycin and amoxicillin prescriptions were ear, nose, and throat infections and bronchitis.

During a five-day course of azithromycin, 29 cardiovascular deaths (85.2 deaths per million courses) and 22 (64.6 per million courses) sudden cardiac deaths occurred. In the matched periods where no antibiotics were prescribed, 41 (29.8 deaths per million periods) cardiovascular deaths and 33 (24 deaths per million periods) sudden deaths occurred. Compared to no antibiotics, azithromycin was associated with an increased risk of cardiovascular death (HR 2.88, p <0.001), sudden cardiac death, and death from any cause.

Compared to amoxicillin and ciprofloxacin, azithromycin was also associated with higher rates of cardiovascular death with hazard ratios of 2.49 (p 0.002) and HR 3.49 (p 0.01), respectively. Patients who took azithromycin had an estimated 47 additional cardiovascular deaths per 1 million courses compared to those who took amoxicillin. The risk of cardiovascular death associated with azithromycin also varied according to overall risk of cardiovascular disease. Those in the highest decile of cardiac risk scores had the highest risk of death while taking azithromycin, with an estimated additional 245 cardiovascular deaths for every 1 million five-day courses of azithromycin.

This study indicates that azithromycin, like other macrolide antibiotics, has serious cardiac effects and is associated with an increased risk of cardiovascular death, especially in patients at greatest risk of cardiovascular disease

(Ray et al. N Engl J Med. 2012; 366:1881-1890.)

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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:

June 15

  • A Way to Avoid Colectomy in Severe Colitis Due To Clostridium difficile
  • Unexplained Dermopathy/Delusions of Parasitosis/Morgellons Disease

June 1

  • Antibiotics for Influenza?
  • Ebola—Inside an Outbreak