Antifungal therapy for febrile neutropenia: issues in clinical trial design.
Amphotericin B therapy for fever during neutropenia became a standard practice approximately 20 years ago. Treatment of febrile neutropenia has since become a common indication sought in the development of new antifungals, with several alternatives approved for 'empirical therapy' based on the results of randomized clinical trials. Recent studies have highlighted problematic issues in trial design and interpretation; inclusion criteria and the definition of success are two examples of controversial issues. Here, issues in trial design will be reviewed to address the question: Can (and should) new antifungals be evaluated for treatment of fever during neutropenia?
Marr
Kieren A
KA
Program in Infectious Diseases, Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue N D3-100, Seattle, WA 98119, USA. kmarr@fhcrc.org
D000818:Animals; D000935:Antifungal Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D005334:Fever / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D009503:Neutropenia / Q000188:drug therapy* / Q000382:microbiology
D000935:Antifungal Agents