Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia (Valley Fever)
Status:
Terminated
Trial end date:
2018-07-31
Target enrollment:
Participant gender:
Summary
This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals
aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility
criteria in endemic regions. This study is designed to provide data on the effectiveness of
early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also
referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in
subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by
their health care provider for acute CAP will be randomized to receive either placebo or 400
mg/day of fluconazole for 42 days. The primary objective is to assess the clinical response
of early empiric antifungal therapy with fluconazole at Day 22 in subjects with
coccidioidomycosis pneumonia and are compliant with the study intervention.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)