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Pathogenesis and Genetics of Disseminated or Refractory Coccidioidomycosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02190266
Recruitment Status : Recruiting
First Posted : July 15, 2014
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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 for up to 5 years. They will have blood tests. They may have other procedures to treat their DCM/RCM.

Condition or disease
Coccidioidomycosis

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Pathogenesis and Genetics of Disseminated or Refractory Coccidiodomycosis
Actual Study Start Date : September 2, 2014
Estimated Primary Completion Date : January 1, 2040
Estimated Study Completion Date : January 1, 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Valley Fever

Group/Cohort
Patients
Patiens with confirmes refractory and/or disseminated coccidioidomycosis.



Primary Outcome Measures :
  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 for up to 5 y... [ Time Frame: Ongoing ]
    Collecting information on coccidioidomycosis.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with confirmed refractory and/or disseminated coccidioidomycosis.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190266


Contacts
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Contact: Merertu Tesso (301) 402-7831 tessom@mail.nih.gov
Contact: Steven M Holland, M.D. (301) 402-7684 sholland@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
University of Arizona
Investigators
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Principal Investigator: Steven M Holland, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02190266    
Other Study ID Numbers: 140146
14-I-0146
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 10, 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Extrapulmonary
Immunodeficiency
Genetics
Infection
Fungal
Additional relevant MeSH terms:
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Coccidioidomycosis
Coccidiosis
Mycoses
Protozoan Infections
Parasitic Diseases