Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
The Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
2 other identifiers
observational
400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedStudy Start
First participant enrolled
September 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
April 15, 2026
April 10, 2026
14.9 years
July 12, 2014
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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...
Collecting information on coccidioidomycosis.
Ongoing
Study Arms (1)
Patients
Patients with confirmed refractory and/or disseminated coccidioidomycosis.
Eligibility Criteria
Patients with confirmed refractory and/or disseminated coccidioidomycosis.
You may qualify if:
- To be eligible for this study, potential participants must meet the following criteria:
- Age greater than or equal to 2 years old.
- a. Enrollment of pediatric patients who are acutely ill or likely to become acutely ill will be deferred until a time when they are considered medically stable by the PI.
- Have a positive Coccidioides antigen load or culture proven (a) refractory pulmonary coccidioidomycosis or (b) disseminated coccidioidomycosis.
- Refractory pulmonary coccidioidomycosis must have occurred for at least 6 months and includes progressive pulmonary involvement without significant pulmonary cavitation.
- Disseminated CM is coccidioidomycosis infection in one or more regions outside of the chest.
- Agree to undergo genetic testing.
- Allow their samples to be stored for future research.
You may not qualify if:
- HIV infection
- Currently taking more than 20 mg/day of prednisone or undergoing active immunosuppressive therapy in the opinion of the investigator
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven M Holland, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2014
First Posted
July 15, 2014
Study Start
September 2, 2014
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
April 15, 2026
Record last verified: 2026-04-10