Back to search results

Observational Study on Infections and Immune Susceptibility

This observational study aims to understand why some people get frequent or unusual infections. Researchers will look for the causes of immune disorders that affect white blood cells, which are important for fighting infections. The goal is to find better ways to diagnose and treat these immune problems. You might be eligible if you or a family member has, or is suspected of having, an infection susceptibility. The study will determine a specific diagnosis for an infection, an underlying reason for susceptibility, or both, either at the time of diagnosis or after a second visit. This study is currently unclear on its recruitment status.

Study design
This is an observational screening study planning to enroll up to 2000 patients and family members over 25 years.
What's involved
You would have up to two visits where blood, urine, saliva, stool, skin biopsy, or wound drainage may be collected for research. These visits are for understanding the infection and its genetic and biochemical causes.
Compensation
The study does not cover the cost of your first visit to NIH for travel or lodging, but it does cover subsequent visits if there is one. Financial assistance may be available based on an assessment.
Follow-up
The primary goal is to determine a diagnosis upon diagnosis or after the second visit. Patients of interest may be asked to join a follow-up study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00404560

Detection and Characterization of Infections and Infection Susceptibility

Recruiting
Not specifiedAges 1+Observational
National Institute of Allergy and Infectious Diseases (NIAID)
~2,000 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
determination of a discrete diagnosis of an infecting agent, an underlying susceptibility trait, or both.
Measured over upon diagnosis or after the second visit

Conditions

Immune Deficiencies

Explore related trials

Autoimmune DiseaseImmune Defects of PhagocytesInborn Error of ImmunitySusceptibility to infections

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Steven M Holland, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Carla D Williams, R.N.
[email protected]
(301) 443-9460
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patients known to have, or suspected of having an infection susceptibility and their healthy blood relatives will be eligible for enrollment.
Participants must be over 1 month of age. There will be no limit as to sex, race or disability.
Patients must have a primary physician outside of the NIH and may be required to submit a letter from their physician that documents their relevant health history.
The participant or the participant's guardian/LAR will be willing and capable of providing informed consent after initial counseling by clinical staff. Separate consent forms for all interventional procedures will be obtained after explanation of the specific procedure.
Patients and relatives must agree to have blood and tissue stored for future studies of the immune system and/or other medical conditions.
Patients and relatives may be concurrently enrolled on other protocols as long as the Principal Investigator is informed.
The patient must be enrolled on this protocol to have relatives enrolled.
Children: Children are included in this study because immune defects may present in early childhood, and early diagnosis or characterization may benefit subjects. Children who do not meet the age and weight criteria for care at the Clinical Center, may have sample collection only.
Decisionally impaired adults: Patients and patient relatives will be able to provide informed consent for themselves or, if they lack the capacity to provide informed consent, the study team will obtain consent from the legally authorized representative. Patients with underlying immune disorders, autoimmune phenomena or severe infections may sometimes present with delirium, encephalopathy, or coma and are therefore unable to provide informed consent. Excluding patients who are unable to provide consent could adversely impact patient access to medical therapy at the NIH as well as adversely impact research recruitment. Excluding patients unable to provide consent would also essentially prohibit us from evaluating patients at higher risk for adverse outcomes and therefore skew our understanding of disease. Similarly, enrolled patient subjects who lose the ability to provide ongoing consent during study participation may continue in the study. The risks and benefits of participation for subjects unable to consent should be identical to those described for less vulnerable patients.

What this trial measures

  • determination of a discrete diagnosis of an infecting agent, an underlying susceptibility trait, or both.upon diagnosis or after the second visit

    patients determined to have a diagnosis or syndrome that requires further study at the NIH will be asked to provide consent for enrollment into an appropriate study for further diagnosis and/or treatment