Actively Recruiting

Age: 1Day - 99Years
All Genders
Healthy Volunteers
NCT01386437

Natural History of Individuals With Immune System Problems That Lead to Fungal Infections

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-28

1200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: \- The immune system is made up of special cells, tissues, and organs that fight infections. Problems with this system may lead to frequent, severe, or unusual fungal infections. These infections are often difficult to treat. Researchers want to collect blood and tissue samples from people who have unusual, persistent or severe fungal infections or immune problems that increase the risk of these infections. Objectives: \- To collect medical information and samples for a long-term study of people with immune system problems that lead to fungal infections. Eligibility: * People with a history of fungal infections caused by immune system problems. * Parents, children, and siblings of this group. * Healthy volunteers not related to the first two groups. Design: * This long-term study may last for up to 25 years. Those in the study may need to provide new information about every 6 months. The procedures for each person may vary with the particular diagnosis and the extent of fungal infection. Healthy volunteers may have only one or two visits. * At the first visit, those in the study will have a full medical history and physical exam. They will also provide blood. * Research procedures may include the following: * Saliva, urine or stool testing * Mouthwash collection for DNA testing * Collection of cheek cells, nail clippings, or vaginal fluid * Tests of leftover tissue or body fluid from previous medical procedures * Skin or oral mucous membrane biopsy * Collection of white blood cells * Followup visits will involve a physical exam and updated medical history. Blood, saliva, urine, or nail clipping samples may be taken for ongoing studies. Any additional tests or exams required by the study doctors may also be done. * Participants may withdraw from the study pool at any time.

CONDITIONS

Official Title

Natural History of Individuals With Immune System Problems That Lead to Fungal Infections

Who Can Participate

Age: 1Day - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults or children with inherited immunodeficiency and diagnosed mucocutaneous or invasive fungal infection
  • Adults or children with acquired immunodeficiency and severe, unusual, persistent, or treatment-resistant mucocutaneous fungal infection
  • Adults or children with acquired immunodeficiency and possible, probable, or proven invasive fungal infection
  • Adults or children with prior unusual, severe, persistent, or treatment-resistant fungal infections who have recovered
  • Adults or children with confirmed or suspected APECED who have not developed chronic mucocutaneous candidiasis
  • Ongoing care by a primary or referring physician
  • Willingness to allow storage of blood and tissue samples for future analysis
  • Willingness to allow genetic testing from blood, body fluids, or tissue
  • Willingness to have HIV testing
  • Ability to provide informed consent or have a legal guardian provide consent
  • Children under 2 years may participate via mail-in specimens
  • Relatives genetically related to patients willing to allow storage of samples and testing
  • Healthy adults aged 18 to 85 willing to allow storage and genetic testing and HIV testing
  • NIH employees are eligible
Not Eligible

You will not qualify if you...

  • Any condition that may interfere with evaluation of immune abnormalities as judged by the investigator
  • Any condition placing the participant at undue risk by study participation
  • Unwillingness to undergo study testing or procedures
  • Hemoglobin less than 7 gm/dL (except for participants only providing leftover pathology specimens or non-blood samples)
  • HIV infection (for healthy volunteers)
  • History of recurrent or severe infections (for healthy volunteers)
  • History of cancer or chemotherapy within past 5 years (for healthy volunteers)
  • Use of systemic corticosteroids or immunosuppressants within past 30 days (for healthy volunteers)
  • Pregnancy or lactation (for healthy volunteers)
  • History of heart, lung, kidney disease, or bleeding disorders (for healthy volunteers)
  • Any condition interfering with comparison of specimens from healthy volunteers to affected subjects

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Michail S Lionakis, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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