Understanding the genetics and immune response in severe coccidioidomycosis
The Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
This study is trying to understand the genetics and immune responses in people over 2 years old who have severe coccidioidomycosis to help improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 2 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | prednisone |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02190266 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the pathogenesis and genetic factors associated with disseminated or refractory coccidioidomycosis, a serious fungal infection. Researchers will analyze the immune systems of affected individuals to identify genetic predispositions and immune responses that contribute to the disease. The study will involve participants over the age of 2 who have been diagnosed with either disseminated or refractory coccidioidomycosis, and will include genetic testing and sample storage for future research. The goal is to enhance understanding of the disease and inform potential therapeutic interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over the age of 2 who have been diagnosed with disseminated or refractory coccidioidomycosis.
Not a fit: Patients with HIV infection or those currently undergoing significant immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment strategies for patients suffering from severe forms of coccidioidomycosis.
How similar studies have performed: While there have been studies on coccidioidomycosis, this specific approach focusing on genetic predisposition and immune response is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: To be eligible for this study, potential participants must meet the following criteria: 1. 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. 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Steven M Holland, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Dawn E Shaw, R.N.
- Email: dawn.shaw2@nih.gov
- Phone: (301) 401-4740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.