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 in endemic areas (FLEET-Valley Fever).
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2021-12
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Introduction: Coccidioidomycosis is a fungal infection endemic in the southwestern United States (US). Primary pulmonary coccidioidomycosis (PPC) is a leading cause of community-acquired pneumonia (CAP) in this region, although its diagnosis is often delayed, leading to lag in antifungal treatment and subsequent morbidity. The impact of early empiric antifungal therapy as part of treatment for CAP in endemic areas on clinical outcomes is unknown. Methods: Phase IV randomized, double-blind, placebo-controlled trial in individuals aged 18 years or older with CAP who met all eligibility criteria in Coccidioides endemic regions in the US. Eligible participants with CAP were randomized to receive either fluconazole (400 mg daily) or matching placebo for 42 days and were subsequently monitored for clinical resolution of their illness. Objectives: The primary objective was to assess the clinical response of early empiric antifungal therapy with fluconazole through Day 22 in subjects with PPC who were adherent to the study intervention. Secondary objectives included: assessments of the impact of early empiric antifungal therapy with fluconazole through Day 22 and 43 in subjects with PPC regardless of adherence, comparisons of the clinical response and its individual components over time by treatment group in subjects with PPC, assessments of days lost from work or school, hospitalization, and all-cause mortality. Discussion: This trial was halted early due to slow enrollment (72 participants in one year, 33 received fluconazole and 39 received placebo). Of those enrolled, eight (11%) met the study definition of PPC. The study design and challenges are discussed.
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Messina, Julia A, Eileen K Maziarz, John Galgiani, Jonathan T Truong, Aung K Htoo, Arash Heidari, Royce H Johnson, Aneesh T Narang, et al. (2021). 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 in endemic areas (FLEET-Valley Fever). Contemp Clin Trials Commun, 24. p. 100851. 10.1016/j.conctc.2021.100851 Retrieved from https://hdl.handle.net/10161/23985.
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Julia Antoinette Messina
I am a Transplant Infectious Diseases Physician who specializes in the care of immunocompromised patients including solid organ and bone marrow transplant recipients and patients with HIV. My research interests are in infections and clinical outcomes in patients with hematologic malignancies.
Eileen Maziarz
John Robert Perfect
Research in my laboratory focuses around several aspects of medical mycology. We are investigating antifungal agents (new and old) in animal models of candida and cryptococcal infections. We have examined clinical correlation of in vitro antifungal susceptibility testing and with in vivo outcome. Our basic science project examines the molecular pathogenesis of cryptococcal infections. We have developed a molecular foundation for C. neoformans, including transformation systems, gene disruptions, differential gene expression screens, and cloning pathogenesis genes. The goal of this work is to use C. neoformans as a model yeast system to identify molecular targets for antifungal drug development. There are a series of clinical trials in fungal infections which are being coordinated through this laboratory and my work also includes a series of antibiotic trials in various aspects of infections. Finally, we have now been awarded a NIH sponsored Mycology Unit for 5 years with 6 senior investigators which is focused on C. neoformans as a pathogenic model system, but will include multiple areas of medical mycology from diagnosis to treatment.
Emmanuel Benjamin Walter
Dr. Emmanuel Walter, MD, MPH, Professor of Pediatrics, serves as the Duke Human Vaccine Institute (DHVI) Chief Medical Officer and directs the Duke Vaccine and Trials Unit. In these roles, Dr. Walter provides strategic and operational leadership for clinical research conducted at the Institute. In addition, he provides oversight of regulatory compliance for DHVI clinical research activities.
Dr. Walter has dedicated his career to advancing research and clinical practice in vaccinology, infectious diseases, and child health. He currently serves as the principal investigator for the Duke Clinical Core of the Collaborative Influenza Vaccine Innovations Centers (CIVICs) funded by the National Institute of Allergy and Infectious Diseases (NIAID). The goal of this work is to evaluate promising next generation influenza vaccine candidates in Phase I and Phase I/II clinical trials and human challenge studies. He is also the Duke Principal Investigator for the CDC-funded Clinical Immunization Safety Assessment Project which conducts studies to identify risk factors and preventive strategies for adverse events following immunization, particularly in special populations. Lastly, he is the Principal Investigator for the CDC-funded coordinating center of the influenza and other respiratory virus vaccine effectiveness network. This work provides national estimates for influenza and other respiratory virus vaccine effectiveness in persons presenting with respiratory illness in the ambulatory setting.
Dr. Walter's focused area of interest include vaccine development, vaccine safety, vaccine effectiveness, vaccine coverage, prevention and treatment of infectious diseases.
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