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)
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 1,000 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 1,000 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.
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.