Active clinical trials for "Coccidioidomycosis"

This study is to collect safety and immunogenicity data for an Rift Valley Fever (RVF) vaccine

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.

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.

Rift Valley fever (RVF), a disease transmitted from livestock (cattle, sheep, goats, camels) to humans more commonly occurs in the East and Central Africa (ECA) regions where more than 15 major epidemics affecting more than one country have been reported over the past 50 years. Within the region, there are specific areas, referred to as hotspots, which support RVF virus maintenance via low-level virus circulation between animals, humans, and mosquitoes. Most outbreaks originate from these hotspots. Our goal is to conduct studies in RVF hotspots in four ECA countries, Kenya, Uganda, Tanzania, and Democratic Republic of Congo (DRC) to determine the burden of RVF disease among humans, wildlife and livestock during inter-epidemic periods (IEPs) and discover circulation of undetected infectious diseases. This information is important for use in developing an early warning system and possibly a vaccination strategy. The study will take place in Uganda, Kenya, Tanzania and Democratic Republic of Congo

Background: - Coccidioidomycosis is caused by a fungus that grows in the southwest United States and parts of Mexico and South America. This disease is caused by breathing dust containing the fungus. It can lead to serious lung and breathing problems. Rarely, the fungus can infect other body parts. This is called disseminated coccidioidomycosis (DCM). If the fungus stays in the lungs for more than 6 months, it is called refractory coccidioidomycosis (RCM). People with DCM or RCM may have difficulty fighting off infection because of immune system problems. Researchers want to study the immune systems of people with DCM or RCM, to learn more about the disease and the best ways to treat it. They also want to learn more about the types of people that get DCM or RCM and about the fungus that causes it. Objectives: - To learn more about DCM and RCM, the fungus that causes these diseases, and the people who get them. Eligibility: - People over age 2 with DCM or RCM. Design: Participants will be screened with a review of their medical records. At the initial visit, participants will have: Medical history and physical exam Blood and urine tests. Some blood may be used for genetic testing. The samples will not include participants names. Participants will be notified only if the tests show something urgent about their DCM/RCM. Researchers think this sort of problem will be rare. Questionnaire about their DCM/RCM Sputum (mucus) collection. They will spit into a cup. Participants will have 1 follow-up visit per year. They will have blood tests. They may have other procedures to treat their DCM/RCM.

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 at Day 22 in subjects with coccidioidomycosis pneumonia and are compliant with the study intervention.

The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of Valley Fever pneumonia will be eligible to participate and will be allocated to receive treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.

This will be a multi-visit study that will take approximately 3 hours in total. Up to 200 subjects from the BUMC Valley Fever and BUMC Dermatology clinics will be enrolled in this study and assigned to one of three cohorts according to timeline of oral anti-fungal therapy. Subjects in Cohort 1 will be randomized to apply topical cholesterol-containing moisturizers to the skin, hair and lips on either the right or left side of the body daily. Measurements of skin barrier function, appearance of skin and hair, and hair samples will be obtained at baseline and at 4 week follow-up visits. Cohorts 2 and 3 will be observational groups at differing points in oral antifungal treatment regimen. Subjects will be randomized to have measurements of skin barrier function and hair and skin characteristics obtained from either the right or left side of the body at baseline and at monthly follow-up visits.

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy adult subjects ages 18 - 45 years inclusive. It is designed to evaluate the safety and PK of single oral doses of VT-1598. Forty-eight subjects will be enrolled in the study at 1 site in the US and randomized to receive either VT-1598 or placebo in 6 dosage cohorts (five fasted cohorts and one fed cohort). Each cohort will have 8 subjects; 6 subjects will receive a single oral dose of VT-1598 and 2 subjects will receive matching placebo. Cohorts 1 - 5 will include 2 sentinel subjects randomized to different treatments. Cohort 6 (receiving treatment after being fed a high-calorie, high-fat meal) will not include sentinel subjects. Subjects will be admitted to the study site before dosing and remain at the study site for safety monitoring and PK assessments for at least 72 hours post-dose. Subjects will return to the study site on study Days 7, 14, and 21 for outpatient safety monitoring and PK assessments. There are no formal hypotheses being tested in this Phase 1 trial study. The primary objectives of this study are 1) to determine the safety of single-ascending oral doses of VT-1598 in healthy adult subjects in a fasted state, and 2) to determine the safety of single oral dose of VT-1598 in healthy adult subjects in a fed state.

To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and participants in Period A may have been eligible to roll over to an open-label, non-comparitive Period B. During Period B, participants received posaconazole for a treatment duration not to exceed 12 months.