Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study ID
- NCT02190266
- Status
- Recruiting
Conditions
- Coccidioidomycosis
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 100 Years
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Sep 2, 2014
- Status verified
- Apr 2026
- Primary completion
- Jul 31, 2029
- Completion
- Jul 31, 2029
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: PatientsPatients with confirmed refractory and/or disseminated coccidioidomycosis.
Primary Outcome Measure
Study patients with refractory and/or disseminated coccidioidomycosis in order to identify known and novel immune defects, characterize the demographics of patients afflicted with this disease, follow disease progression in patients, and charact... [ Time Frame: Ongoing ]
Central Contacts
- Dawn E Shaw, R.N.(301) 401-4740
- Steven M Holland, M.D.(301) 402-7684
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |