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NCT02663674 · ClinicalTrials.gov registry record · Phase 4
Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia (Valley Fever)
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT02663674: Clinical Trial Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02663674 is a Phase 4 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02663674, a Phase 4 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study 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.
Primary Outcome
The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptom
Interventions
- OTHER Placebo
- DRUG Fluconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-12-29 |
| Est. Completion | 2018-07-31 |
| Phase | Phase 4 |
Why NCT02663674 stopped before completion
NCT02663674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02663674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02663674 about?
NCT02663674 is a clinical study titled "Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia (Valley Fever)". 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 ...
What is the current status of trial NCT02663674?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2015-12-29. Estimated completion is 2018-07-31.
What interventions are being tested in trial NCT02663674?
The interventions under investigation include: Placebo (OTHER), Fluconazole (DRUG).
Who is sponsoring clinical trial NCT02663674?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02663674's enrollment target sits among peer trials
72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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