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A Randomized, Double-blind, Placebo-controlled Clinical Trial of Fluconazole as Early Empiric Treatment of Coccidioidomycosis Pneumonia (Valley Fever) in Adults Presenting With Community Acquired Pneumonia (CAP) in Endemic Areas (FLEET-Valley Fever)
Scottsdale/Phoenix, Ariz.
This is a Phase IV randomized, double-blinded, placebo-controlled study in 1000 individuals aged 18 years or older, with community acquired pneumonia (CAP) who meet all eligibility criteria in endemic regions. This study is designed to provide data on the effectiveness of early antifungal treatment (Fluconazole, 400 mg/day) for coccidioidomycosis pneumonia (also referred to as Valley Fever (VF) Pneumonia or acute onset valley fever) vs. placebo in subjects with coccidioidomycosis pneumonia. Patients who are prescribed antibacterials by their health care provider for acute CAP will be randomized to receive either placebo or 400 mg/day of fluconazole for 42 days. The primary objective is to assess the clinical response of early empiric antifungal therapy with fluconazole through Day 22 in subjects with coccidioidomycosis pneumonia and are compliant with the study intervention.
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Convalescent Plasma to Limit Coronavirus Associated Complications: A Randomized, Double-Blind, Controlled, Phase 2 Study Comparing the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 non-immune)
Plasma Among Outpatients with Symptomatic COVID-19 (CSSC-004)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to assess the effectiveness and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
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Specimen Collection for Early Identification of Acute Pulmonary Coccidioidomycosis
Scottsdale/Phoenix, Ariz.
The purpose of this study is to identify, recruit, and enroll patients with community-acquired pneumonia (CAP) to collect their blood, sputum, urine, and a nasopharyngeal swab for specimen storage. The study also aims to develop a biomarker assay to detect circulating antigen in patients infected with Coccidioides.
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Testing and Validating a Point of Care Lateral Flow Assay for Coccidioidomycosis
Scottsdale/Phoenix, Ariz.
The purpose of this study is to test the accuracy of a point-of-care lateral flow assay for coccidioidomycosis. In seropositive patients, we will take 1 drop of blood for the lateral flow test, and compare to results of the complement fixation/immunodiffusion test (standard assay) that is conducted within 2 weeks of the lateral flow assay.
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