August 1, 2007

Key Studies Proposed to Answer Basic Questions

What is the optimal duration of therapy for cellulitis? Are two drugs better than one for community acquired pneumonia (CAP)? Are antibiotics really necessary when treating otitis media?

rice pull quote 3.2The evidence supporting the standard of care for these and other common infections is surprisingly weak. Inappropriate use of antibiotics is a major factor driving the growing epidemic of antibiotic-resistant infections. With a movement on the rise to penalize institutions for health care-associated infections, infectious diseases experts are looking for solid answers.

“Despite using antibiotics for decades, we still don’t know how to use them optimally,” said Louis B. Rice, MD, chair of IDSA’s Research on Resistance Work Group. For years, IDSA has been urging the National Institute of Allergy and Infectious Diseases (NIAID) to study these issues. This summer, the Society proposed three multi-center, controlled clinical trials using generic antibiotics to answer key questions about cellulitis, CAP, and otitis media in children, and to lay the groundwork to answer more.

  • Three days vs. seven to 10 days of antibiotic therapy for uncomplicated, community acquired cellulitis. The optimal duration of therapy for cellulitis, an extremely common infection for which large quantities of broad-spectrum antibiotics are prescribed, has not been defined. Shorter courses may work just as well as longer courses, while reducing exposure to antibiotics and the growth of resistant bacteria.
  • A three-armed study of community acquired pneumonia comparing seven days of aß-lactam, seven days ofß-lactam plus azithromycin, and three days ofß-lactam alone. Current guidelines recommend an agent against atypical pathogens, but there is evidence suggesting this does not improve outcomes. Also, some studies suggest shorter therapy with a ß-lactam may be just as effective as the current seven-day standard. Definitive answers are needed.
  • Amoxicillin or azithromycin plus analgesics vs. placebo plus analgesics for children older than 6 months with middle ear infections. More prescriptions for antibiotics are written for children with acute otitis media than anything else, but the evidence that antibiotics improve the time to resolution of symptoms is weak.

These issues have gone unresolved for so long because antibiotics have long been considered relatively benign medications with little risk to the patient, Dr. Rice said. The prevailing wisdom has been that the risk to the patient of an infection recurring is greater than the risk of taking more antibiotics than necessary. “But now we have MRSA, we have resistant Klebsiella and Pseudomonas, we have Acinetobacter, and we have C. difficile,” Dr. Rice said. “We have to weigh the risks and benefits differently.” 

IDSA drew up this proposal at the request of NIAID and has been in close communication with the institute. IDSA’S ultimate aim is to persuade NIAID develop the infrastructure to carry out more trials on antimicrobial usage.

This summer, NIAID has awarded two contracts to address the cellulitis question. These multisite, phase II/III clinical trials will use generic antibiotics to find optimal ways to treat uncomplicated skin and soft tissue infections caused by community acquired MRSA. The goal is to preserve the efficacy of vancomycin, linezolid, and other final-option drugs.

Click here to read details of IDSA’s proposal for the three clinical trials.

NIAID’s news release on the CA-MRSA trials can be found here.

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