Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT03908632
Eligibility Criteria:
Inclusion Criteria:
Step 1 Subject Inclusion Criteria:
1. Aged \> / = 14 years and presenting for clinical care in coccidioidomycosis endemic areas.
2. Diagnosis of community acquired pneumonia (CAP) established by a health care provider.
3. Pulmonary opacity on chest X-ray or computerized tomography (CT) scan consistent with CAP.
4. Onset of symptoms related to current CAP diagnosis within 28 days prior to enrollment.
5. 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.
6. Willing and able to comply with study procedures and complete study visits.
7. Willing to allow access to medical records, and medical records are available to the study team.
Step 2 Subject Inclusion Criteria:
1. Aged \> / = 14 years
2. Presence of at least one influenza-like sign or symptom (e.g. fever, chest pain, cough, myalgia, arthralgia, and headache.
3. Onset of any symptoms no earlier than 7 weeks prior to enrollment into Step 2.
4. Opacity/pleural effusion diagnosed by chest radiograph or computerized tomography (CT) scan .
5. 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
6. 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.
7. Willing and able to comply with study procedures and complete study visits.
8. Willing to allow access to medical records, and medical records are available to the study team.
Exclusion Criteria:
Step 1 Subject Exclusion Criteria:
1. 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.
2. Hospitalization within 14 days prior to the onset of pneumonia symptoms.
3. Presence of cavitary lung disease.
4. Evidence of disseminated, extrathoracic disease.
Step 2 Subject Exclusion Criteria:
1. 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.
2. Presence of cavitary lung disease.
3. Evidence of disseminated, extrathoracic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
99 Years
Study:
NCT03908632
Study Brief:
Protocol Section:
NCT03908632