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NCT03908632 · ClinicalTrials.gov registry record
An Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis in Persons Aged > / = 14 Years Presenting With Community Acquired Pneumonia (CAP) in Endemic Areas (SAnds-PPC)
A clinical trial of Pneumonia and Coccidioidomycosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 651
- Enrollment target
- 6
- Study locations
NCT03908632: Completed study of Pneumonia and Coccidioidomycosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03908632 is a study of Pneumonia and Coccidioidomycosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 651 participants, below the 4,506-participant average among 47 other Pneumonia trials with a reported enrollment target (86% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03908632, a study of Pneumonia and Coccidioidomycosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 651 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is an observational study in 750 individuals aged 14 years or older, diagnosed with Community Acquired Pneumonia (CAP) who meet all eligibility criteria in Coccidioides endemic regions. This study is designed to provide data on the prevalence of primary pulmonary coccidioidomycosis among persons presenting with CAP in endemic regions. Among individuals diagnosed with primary pulmonary coccidioidomycosis, we aim to describe the clinical course, predictors of the clinical course and compare the response to prescribed antifungal therapy versus no antifungal therapy. The hypothesis for patients with primary pulmonary coccidioidomycosis is that early treatment with antifungal therapy is effective in reducing the frequency, severity and associated adverse outcomes of infection with recently acquired coccidioidomycosis pneumonia. The study will be divided into Step 1 and Step 2. Step 1 will identify which subjects have primary pulmonary coccidioidomycosis based on the case definition for the protocol and Step 2 will follow subjects who meet the case definition and will observe their clinical management and clinical outcomes. Subjects will enroll in Step 1 within 28 days of symptom onset. In Step 1, blood work for serologic determination of Coccidioides infection will be drawn at the time of enrollment (Day 1), and again 21 days later if a positive result is not reported at Day 1. Subjects with a diagnosis of primary pulmonary coccidioidomycosis confirmed by positive serologic testing during Step 1 will enter Step 2 within 21 days of a positive test result; subjects with a negative serology at Day 1 and Day 22 will not be followed further. Subjects referred to the study after a diagnosis of primary pulmonary coccidioidomycosis confirmed by positive serologic testing will also be allowed to enter Step 2 directly within 21 days of a positive test result and within 7 weeks of symptom onset, as long as they meet study enrollment criteria. The primary objective is to assess
Conditions Studied
Study Locations (6)
California
- Kaiser Permanente Chester Avenue Medical Offices - Pulmonology - Bakersfield
- Kern Medical Center - Bakersfield
- UCSF Fresno Center for Medical Education and Research - Clinical Research Center - Fresno
- Kaiser Permanente Antelope Valley Medical Offices - Infectious Diseases - Lancaster
Arizona
- Banner - University Medical Center Advanced Lung Disease Clinic - Phoenix - Phoenix
- The University of Arizona - Banner University Medical Center Tucson Campus - Tucson - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 651 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2023-12-05 |
What the finished NCT03908632 record still lists
NCT03908632 is an observational study that tracks outcomes without assigning an intervention. The registered 651 participants enrollment target is mid-sized for trials with a published cap, below the 4,506-participant average among 47 other Pneumonia trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Pneumonia appearing as the primary indexed condition, and to 0 interventions.
NCT03908632 lists 6 locations in 2 states (California, Arizona).
Frequently Asked Questions
What is clinical trial NCT03908632 about?
NCT03908632 is a clinical study titled "An Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis in Persons Aged > / = 14 Years Presenting With Community Acquired Pneumonia (CAP) in Endemic Areas (SAnds-PPC)". This is an observational study in 750 individuals aged 14 years or older, diagnosed with Community Acquired Pneumonia (CAP) who meet all eligibility criteria in Coccidioides endemic regions. This study is designed to provide data on the prevalence of primary pulmonary coccidioidomycosis among person...
What is the current status of trial NCT03908632?
This trial is currently completed. The enrollment target is 651 participants. The study started on 2019-02-14. Estimated completion is 2023-12-05.
What conditions does trial NCT03908632 study?
This clinical trial studies the following conditions: Pneumonia, Coccidioidomycosis.
Who is sponsoring clinical trial NCT03908632?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03908632 being conducted?
This trial has 6 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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651 12th of 47 higher than 36 of 47 other Pneumonia trials
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