Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-03-01 @ 12:50 PM
Study NCT ID:
NCT02190266
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2014-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
The Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis
Status:
RECRUITING
Status Verified Date:
2025-08-14
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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.
Detailed Description:
Coccidioidomycosis (CM) is a fungal disease endemic to the southwestern United States, Northern Mexico, and parts of South America. About 150,000 CM infections are estimated to occur in the United States each year, of which 60% are thought to be asymptomatic. Symptomatic patients typically present with a respiratory syndrome likened to community-acquired pneumonia, while less than 1% of infected individuals are thought to develop refractory disease with or without dissemination. Disseminated infection rarely resolves spontaneously and, although any organ can be affected, tends to involve the skin, lymph nodes, central nervous system and/or the skeletal system. While the risk of disseminated infection is increased in immune suppressed patients, many individuals with no significant prior history have developed debilitating, widespread infection. Causes of refractory and/or disseminated disease in previously healthy individuals have only recently begun to be elucidated, including mutations in the IFNy/IL-12 pathway.
We seek to better characterize the genetic predisposition and treatment of refractory
and/or disseminated coccidioidomycosis. Specifically, we will examine multiple immune factors, characterize the demographics of patients afflicted with this disease, and examine the phylogeny of the infecting organisms. This information will reveal endogenous pathways that might be targets for therapeutic intervention.
We seek to better characterize the genetic predisposition and treatment of refractory
and/or disseminated coccidioidomycosis. Specifically, we will examine multiple immune factors, characterize the demographics of patients afflicted with this disease, and examine the phylogeny of the infecting organisms. This information will reveal endogenous pathways that might be targets for therapeutic intervention.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 14-I-0146 | None | None | View |