Clinical Trial: Early Fluconazole Treatment for Coccidiodomycosis Pneumonia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled Clinical Trial of Fluconazole as Early Empiric Treatment of Coccidioidomycosis Pneumonia (Valley Fever

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 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 through Day 22 in subjects with coccidioidomycosis pneumonia and are compliant with the study intervention.

Detailed 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. Blood work for serologic determination of coccidioidomycosis infection will be drawn at the time of randomization (Day 1), and again on Days 15, 22, 29. On Day 43, subjects will be informed of their coccidioidomycosis status and their treatment assignment. Those who receive placebo and are coccidioidomycosis negative will be dismissed from the study after the Day 43 visit; those who are coccidioidomycosis positive will be referred to a health care provider with the results of their serology testing and their treatment assignment for further treatment as indicated and will return for follow-up visits on Days 90 and 180. Those who receive fluconazole and are coccidioidomycosis negative will remain in the study for an additional 6 days for safety follow-up only; those who are coccidioidomycosis positive 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 return at Days 90 and 180 and will be contacted via phone on Day 49. The study duration will be approximately 72 months, and the subject participant duration will be from 42 days to approximately 6 months. The primary clinical outcome will be time to achieve clinical response based on signs and symptoms of pneumonia via FLEET CAP score through Day 22. Sec
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: The cumulative incidence of a clinical response by Day 22 among subjects with coccidioidomycosis pneumonia in each treatment group. The recall period for symptom assessments will be during the past week, with the exception of fever and hypoxia. [ Time Frame: Day 1 to 22 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cumulative incidence of clinical response among all randomized subjects, regardless of coccidioidomycosis status or adherence to study drug, in each treatment group (Intent-to-treat population). [ Time Frame: Day 1 to 22 ]
  • Number of all-cause mortality by treatment group [ Time Frame: Day 1 to 43 ]
  • Number of days of school or work missed due to illness in each treatment group. [ Time Frame: Day 1 to 43 ]
  • Number of hospitalization events by treatment group. [ Time Frame: Days 1 to 43 ]
  • The cumulative incidence of a clinical response among subjects with coccidioidomycosis pneumonia in each treatment group [ Time Frame: Day 1 to 22 ]
  • The cumulative incidence of a clinical response among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Day 1 to 43 ]
  • The mean for each component of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The mean for the responses to the individual items of the PROMIS Item Bank v2.0 [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The mean for the SF-12v2 instrument (mental component summary (MCS) and physical component summary (PCS) scores) [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The mean of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The median for each component of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The median for the responses to the individual items of the PROMIS Item Bank v2.0 [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The median for the SF-12v2 instrument (mental component summary (MCS) and physical component summary (PCS) scores) [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The median of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The quartiles for each component of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The quartiles for the responses to the individual items of the PROMIS Item Bank v2.0 [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The quartiles for the SF-12v2 instrument (mental component summary (MCS) and physical component summary (PCS) scores) [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The quartiles of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]


Original Secondary Outcome:

  • The median for the responses to the individual items of the PROMIS Item Bank v2.0 [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The mean for the responses to the individual items of the PROMIS Item Bank v2.0 [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The quartiles for the SF-12v2 instrument (mental component summary (MCS) and physical component summary (PCS) scores) [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The mean for each component of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The median for each component of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The cumulative incidence of a clinical response among subjects with coccidioidomycosis pneumonia in each treatment group [ Time Frame: Day 1 to 22 ]
  • Cumulative incidence of clinical response among all randomized subjects, regardless of coccidioidomycosis status or adherence to study drug, in each treatment group (Intent-to-treat population). [ Time Frame: Day 1 to 22 ]
  • Number of all-cause mortality by treatment group [ Time Frame: Day 1 to 43 ]
  • The cumulative incidence of a clinical response among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Day 1 to 43 ]
  • Number of days of school or work missed due to illness in each treatment group. [ Time Frame: Day 1 to 43 ]
  • The mean for the SF-12v2 instrument (mental component summary (MCS) and physical component summary (PCS) scores) [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The quartiles for the responses to the individual items of the PROMIS Item Bank v2.0 [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The quartiles for each component of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The mean of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • Number of hospitalization events by treatment group. [ Time Frame: Days 1 to 43 ]
  • The median for the SF-12v2 instrument (mental component summary (MCS) and physical component summary (PCS) scores) [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The quartiles of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]
  • The median of the FLEET CAP score among subjects with coccidioidomycosis pneumonia in each treatment group. [ Time Frame: Days 3, 15, 22, 29, 43, 90 and 180 ]


Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: January 15, 2016
Date Started: December 29, 2015
Date Completion: January 15, 2021
Last Updated: February 9, 2017
Last Verified: January 4, 2017