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)
Condition: Coccidioidomycosis; Pneumonia
MeSH terms: Pneumonia; Coccidioidomycosis; Coccidiosis
Study type: Observational

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.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      Venous blood samples (approximately 10 mL) to determine Coccidioides antibodies for entry
      will be performed locally at the sites for Step 1 Day 1, and if negative this will be
      repeated at Day 22. Erythrocyte sedimentation rate (ESR), high sensitivity C-reactive protein
      (hsCRP), and procalcitonin will be measured on Step 1 Day 1, or if enrolled directly into
      Step 2, at Step 2 Day 1. Total blood volume for subjects participating only in Step 1 will be
      up to 65 ml (95 mL for subjects consenting to additional sample collection for future use).
      Total blood volume collected per participant who participates in Step 1 and Step 2 is up to
      95 mL (up to 155 mL for subjects consenting to additional sample collection for future use).
      Volumes may be higher for subjects with additional clinic visits after Step 2 Visit 06 due to
      persistent or disseminated disease.
    
Keywords: Community Acquired Pneumonia; Endemic Areas; Observational Study; Primary Pulmonary Coccidioidomycosis