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Evaluation of Immune Abnormalities in Recurrent Infections

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Study AimThe study aims to observe and evaluate immune abnormalities in individuals with recurrent infections to identify potential infecting agents or susceptibility traits.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Immune Defects

From 1 Months to 100 Years
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 1993

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactDawn E Shaw, R.N.
Last updated: September 23, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 1993Actual date on which the first participant was enrolled.

This study focuses on understanding why some people experience frequent or unusual infections. It involves patients who have these infections and their family members. By studying them, researchers aim to identify any immune system abnormalities that might be causing these infections. This research is important because it could lead to better ways to diagnose and treat these conditions, and may even help develop new therapies in the future. Participants in the study will provide samples such as blood, urine, saliva, and other bodily substances. These samples will be used to look for signs of immune system issues. Researchers will carefully monitor participants over time to see if their condition improves or worsens. The study's main goal is to find out if there's a specific bacteria or virus causing the infections, or if there's an underlying issue with the immune system. This information could help in developing more effective treatments for those with similar conditions.

Official TitleDetection and Characterization of Host Defense Defects 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactDawn E Shaw, R.N.
Last updated: September 23, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
3600 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 1 Months to 100 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Immune Defects
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Healthy Volunteer to serve as controls
Group II
Patients known to have or suspected of having an immune defect significantly or primarily involving the phagocytes
Group III
blood relatives of patients
Study Objectives
Primary Objectives

The primary endpoint of this study will be determination of a discrete diagnosis of an infecting agent, an underlying susceptibility trait, or both.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
National Institutes of Health Clinical CenterBethesda, United StatesSee the location

Recruiting
One Study Center
Evaluation of Immune Abnormalities in Recurrent Infections | PatLynk