Interferon-Gamma Release Assays in Tuberculosis (TB) - HIV Co-infected Children

NCT00604617 | Completed

• 2 other identifiers: 07-0061R01AI076199
• Study Type: observational
• Target: 564
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis (TB) is a disease affecting the lungs that is caused by a germ spread by coughing. TB infection is currently diagnosed by a skin test that has limited accuracy. The purpose of this study is to look at the reliability of a new blood test for diagnosing TB infection in children. Study participants will include 300 HIV-infected (HIV infection is a viral infection that causes disease which destroys the body's ability to protect itself from infection and disease.) children and 500 HIV-uninfected children, ages 3 months to 5 years, residing in the Khayelitsha and Ravensmead/Uitsig Communities of the Western Cape Province, South Africa. Study procedures will include questionnaires, HIV and TB testing, which will be performed by blood and skin tests. Participants may be involved in study related procedures for up to 24 months.

Conditions

Tuberculosis; HIV

Keywords

Mycobacterium tuberculosis; Tuberculin Test; South Africa

Interventions

Interferon-Gamma Release Assay PROCEDURE

IGRAs

RT-23 DRUG

TST - tuberculin skin test

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will include 300 HIV-infected (HIV infection is a viral infection that causes disease which destroys the body's ability to protect itself from infection and disease.) children and 500 HIV-uninfected children, ages 3 months to 5 years, residing in the Khayelitsha and Ravensmead/Uitsig Communities of the Western Cape Province, South Africa.

You may qualify if:

• Age less than or equal to 5 years.
• Presence of written informed consent from the parent or legal guardian.

You may not qualify if:

• Children less than 3 months of age.
• Children that weigh less than 5 kg.
• Children that have laboratory-documented anemia (Hg \< 9mg/dL).
• Children who are currently on antituberculosis therapy for TB disease.
• Informed consent is not obtained for all study procedures.
• Children will be excluded from primary data analysis if they are diagnosed with TB disease during follow-up.
• Enrollment will be deferred in children who have received live measles or polio vaccine within the past 6 weeks and children who have severe acute illness including acute upper or lower respiratory tract infection, acute diarrhea or central nervous system disease.

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Stellenbosch

Cape Town, Western Cape, 7500, South Africa

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Interferon-gamma Release Tests

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 30, 2008
• Study Start: January 26, 2009
• Primary Completion: August 21, 2012
• Study Completion: August 21, 2012
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

ZA (1)