Recruiting

Coccidioidomycosis

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT02190266

Conditions

Coccidioidomycosis

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Coccidioidomycosis

Study ID

NCT02190266

Start date

Sep 2, 2014

Status verified date

Jun 23, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:

To be eligible for this study, potential participants must meet the following criteria:

1. Age >= 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.
2. Have a positive Coccidioides antigen load or culture proven (a) refractory pulmonary coccidioidomycosis or (b) disseminated coccidioidomycosis.

1. Refractory pulmonary coccidioidomycosis must have occurred for at least 6 months and includes progressive pulmonary involvement without significant pulmonary cavitation.
2. Disseminated CM is coccidioidomycosis infection in one or more regions outside of the chest.
3. Agree to undergo genetic testing.
4. Allow their samples to be stored for future research.

EXCLUSION CRITERIA:

1. HIV infection
2. Currently taking more than 20 mg/day of prednisone or undergoing active immunosuppressive therapy in the opinion of the investigator
3. 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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients

Patients 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 and Locations

Central contacts

Dawn E Shaw, R.N.

(301) 401-4740dawn.shaw2@nih.gov

Steven M Holland, M.D.

(301) 402-7684sholland@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Jul 28, 2026

Last verified

Jun 23, 2026

Keywords

  • Extrapulmonary
  • Immunodeficiency
  • Genetics
  • Infection
  • Fungal
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-07-28.