Ignite Creation Date:
2024-05-06 @ 1:00 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03908632
Status:
COMPLETED
Last Update Posted:
2024-01-19
First Post:
2019-03-27
Brief Title:
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
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-07-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 the prevalence of primary pulmonary coccidioidomycosis PPC in subjects with community acquired pneumonia CAP in coccidioidomycosis endemic areas
Detailed Description:
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 the prevalence of primary pulmonary coccidioidomycosis PPC in subjects with community acquired pneumonia CAP in coccidioidomycosis endemic areas The secondary objectives are divided into two categories For subjects with CAP in coccidioidomycosis endemic areas the secondary objectives are 1 To determine demographic clinical and laboratory factors that predict PPC 2 To describe the practice of empiric antifungal treatment of subjects with CAP For subjects with confirmed primary pulmonary coccidioidomycosis the secondary objectives are 1 To describe the clinical course of primary pulmonary coccidioidomycosis from earliest presentation 2 To assess the demographic clinical laboratory and treatment predictors of the clinical course of primary pulmonary coccidioidomycosis 3 To describe the practice of antifungal treatment of subjects with confirmed primary pulmonary coccidioidomycosis 4 To compare the outcomes of antifungal therapy vs no therapy for primary pulmonary coccidioidomycosis as measured by clinical signs and symptoms functional scores of health and well-being and ability to participate in social roles and activities time missed from school and work dissemination and mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None