Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02663674
Status:
TERMINATED
Last Update Posted:
2019-07-05
First Post:
2016-01-15
Brief Title:
Efficacy Study of Fluconazole to Treat Coccidioidomycosis Pneumonia Valley Fever
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Clinical Trial of Fluconazole as Early Empiric Treatment of Coccidioidomycosis Pneumonia Valley Fever in Adults Presenting With Community Acquired Pneumonia CAP in Endemic Areas FLEET-Valley Fever
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to lack of feasibility of study design
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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 mgday 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
Detailed Description:
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 mgday 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 mgday of fluconazole for 42 days Blood work for serologic determination of coccidioidomycosis infection will be drawn at the time of randomization Day 1 and again on Days 22 29 and 43 On Day 43 subjects will be informed of their treatment assignment and results of serologic testing from Days 1 22 and 29 At Day 43 those subjects who did not meet the protocol defined case definition for CAP caused by acute coccidioidomycosis and who did not receive fluconazole will be dismissed from the study and referred to a health care provider with the results of their serology testing and their treatment assignment All subjects who received fluconazole will be evaluated for safety follow up at Day 49 At Day 49 those subjects who did not meet the protocol defined case definition for CAP caused by acute coccidioidomycosis will be dismissed from the study and referred to a health care provider with the results of their serology testing and their treatment assignment Subjects who did meet the protocol defined case definition for CAP caused by acute coccidioidomycosis infection will be referred to a healthcare provider with the results of their serology testing and their treatment assignment for further treatment as indicated and will be contacted by telephone on Days 90 and 180 The study duration will be approximately 72 months and the subject participant duration will be from 42 days to approximately 6 months The primary objective is to assess the clinical response of early empiric antifungal therapy with fluconazole at Day 22 in subjects with coccidioidomycosis pneumonia who are adherent to the study intervention The secondary objectives are 1 To assess the clinical response of early empiric antifungal therapy with fluconazole at Day 22 in subjects with coccidioidomycosis pneumonia regardless of adherence with the study intervention 2 To assess the clinical response of early empiric antifungal therapy with fluconazole at Day 43 in subjects with coccidioidomycosis pneumonia regardless of adherence with the study intervention 3 To compare the clinical response and its individual components over time by treatment group in subjects with coccidioidomycosis pneumonia 4 To assess the impact of early empiric antifungal therapy with fluconazole on days lost from work or school and responses to the SF-12v2 and PROMIS Item Bank v20 - Ability to Participate in Social Roles and Activities - Short Form 4a in subjects with coccidioidomycosis pneumonia 5 To assess the effect of early empiric antifungal therapy with fluconazole through Day 43 in subjects with coccidioidomycosis pneumonia on all-cause mortality by treatment group and 6 To assess whether early empiric antifungal therapy with fluconazole at Day 22 is non-inferior to placebo as defined by clinical response at Day 22 in all randomized subjects regardless of coccidioidomycosis pneumonia status or adherence with study intervention with baseline and follow-up FLEET-CAP scores
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN272201300017I | None | None | None |