An observational study in Coccidioidomycosis and Pneumonia, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 6 sites in United States. Open to participants aged 14 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-01-19.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 651 is above the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
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Step 1 will include at least 750 persons aged 14 and older diagnosed with community acquired pneumonia (CAP) in coccidioidomycosis endemic areas. Step 2 will involve at least 200 persons aged 14 and older with primary pulmonary coccidioidomycosis.
Step 1 Subject Inclusion Criteria:
Must be able to understand the study and provide informed consent.*
*If aged \< 18 years, the parent(s) or guardian must be able to understand the study and provide informed consent, with the assent of the minor.
Step 2 Subject Inclusion Criteria:
Positive result for any serologic test confirming coccidioidomycosis obtained within 21 days prior to enrollment into Step 2.*
* The assays considered for this criterion are: coccidioidal immunoglobulin M (IgM) by immunodiffusion, enzyme immunoassay (EIA), latex agglutination or tube precipitin OR coccidioidal immunoglobulin G (IgG) by immunodiffusion, EIA, or complement fixation. The interpretation of positive or negative is per the reporting laboratory instructions
Must be able to understand the study and provide informed consent.**
**If aged \<18 years, the parent(s) or guardian must be able to understand the study and provide informed consent, with the assent of the minor.
Exclusion Criteria:
Step 1 Subject Exclusion Criteria:
Have documented microbiologically- or serologically-confirmed past infections with Coccidioides.*
*An initial positive serologic test obtained within 21 days inclusive prior to enrollment is permissible.
Step 2 Subject Exclusion Criteria:
Have documented microbiologically- or serologically-confirmed past infections with Coccidioides.*
*An initial positive serologic test obtained within 21 days inclusive prior to enrollment is permissible.
Subjects 14 years or older diagnosed with Community Acquired Pneumonia (CAP) and positive serology for primary pulmonary coccidioidomycosis (PPC) will enroll in Step 1 within 14 days of symptom onset, n=750
Subjects with a diagnosis of primary pulmonary coccidioidomycosis (PPC) confirmed by positive serologic testing during Step 1 will enter Step 2 within 21 days of their test collection date, n=200
Proportion of subjects with primary pulmonary coccidioidomycosis (PPC) among subjects with Community Acquired Pneumonia CAP) in Step 1
Time frame: Day 1 through Day 22
Associations between chest radiograph and antifungal treatment for PPC, Step 2
Time frame: Day 1 through Day 730
Associations between Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis (SAnds-PPC) and antifungal treatment for PPC, Step 2
Time frame: Day 1 through Day 730
Associations between severity and antifungal treatment for PPC, Step 2
Time frame: Day 1 through Day 730
Compare change in chest radiograph findings score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 730
Compare disease severity score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 365
Compare mortality rates for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 365
Compare percent of subjects that develop persistent or disseminated PPC for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 85 through Day 730
Compare SAnds-PPC score for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 730
Compare time missed from school and work for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 180
Descriptive statistics of subjects' demographics in Step 1
Time frame: Day 1
Descriptive statistics of subjects' Erythrocyte Sedimentation Rate (ESR) in Step 1
Time frame: Day 1
Descriptive statistics of subjects' High sensitivity C-reactive protein (hsCRP) in Step 1
Time frame: Day 1
Descriptive statistics of subjects' Observational Study to Assess the Prevalence and Outcomes of Primary Pulmonary Coccidioidomycosis (SAnds-PPC) in Step 1
Time frame: Day 1
Descriptive statistics of subjects' procalcitonin in Step 1
Time frame: Day 1
Descriptive statistics of subjects' serologic titers in Step 1
Time frame: Day 1
Frequency of prescription of antifungal therapy prescribed for Community Acquired Pneumonia (CAP) for Step 1
Time frame: Day 1 through Day 22
Frequency of prescription of antifungal therapy prescribed for primary pulmonary coccidioidomycosis (PPC) for Step 2
Time frame: Day 1 through Day 730
Mean of change in chest radiograph findings score as a part of standard of care, Step 2
Time frame: From 4 to 8 weeks after Initial chest x-ray date
Mean of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Mean of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Mean of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Mean of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Mean of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Median of change in chest radiograph findings score as a part of standard of care, Step 2
Time frame: From 4 to 8 weeks after Initial chest x-ray date
Median of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Median of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Median of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Median of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Median of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Quartiles of change in chest radiograph findings score as a part of standard of care, Step 2
Time frame: From 4 to 8 weeks after Initial chest x-ray date
Quartiles of disease severity score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Quartiles of the disease severity score for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Quartiles of the modified SAnds-PPC score (clinical scoring system) for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Quartiles of the SAnds-PPC score (clinical scoring system) for subjects with persistent or disseminated primary pulmonary coccidioidomycosis (PPC), Step 2
Time frame: Day 180 through Day 365
Quartiles of time to resolution of each symptom contributing to the modified SAnds-PPC score for subjects with primary pulmonary coccidioidomycosis (PPC) from Step 2
Time frame: Day 1 through Day 85
Summary statistics for PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 365
Summary statistics for the mental component summary (MCS) and the physical component summary (PCS) scores of the SF-12v2 instrument for subjects that are prescribed antifungal therapy vs. no therapy for PPC, Step 2
Time frame: Day 1 through Day 365
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)