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Diagnosis of Tuberculosis Infection in HIV Co-infected Children (ThrasherIGRA)

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. Read our disclaimer for details. Identifier: NCT00541294
Recruitment Status : Unknown
Verified August 2010 by Case Western Reserve University.
Recruitment status was:  Recruiting
First Posted : October 10, 2007
Last Update Posted : August 3, 2010
Thrasher Research Fund
Information provided by:
Case Western Reserve University

Brief Summary:

Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival.

The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited.

Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic testing can accurately identify children with TB infection. In a community with high rates of TB and HIV infection, the following specific aims will be investigated in HIV-infected and uninfected children:

  1. assess the agreement between the TST and blood-based diagnostic testing,
  2. compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure,
  3. measure the impact of age, nutritional and immune status on children's response to blood-based testing,
  4. describe factors that might modify children's response to testing over time, and 5) examine the effect of environmental exposures and previous vaccination on the TST, blood-based testing and other measures of immune responses to TB.

Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in children include 1) timely institution of treatment for TB infection to prevent severe disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of childhood TB infection also prevents future contagious adult disease, thus decreasing community transmission. Blood-based diagnostic testing may also be able to identify children that are more likely to become ill following TB infection. Therefore, blood-based diagnostic testing has great potential to improve TB control and the health of HIV-infected and uninfected children, their households and communities.

Condition or disease
Latent Tuberculosis Infection Tuberculosis HIV Infections

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Study Type : Observational
Estimated Enrollment : 250 participants
Time Perspective: Prospective
Official Title: Diagnosis of Tuberculosis Infection in HIV Co-infected Children
Study Start Date : October 2007
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

M.tb unexposed HIV-infected and uninfected children <15 years of age
M.tb exposed HIV-infected and uninfected children <15 years of age

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV seropositive and seronegative South African children (6months to 15years) with and without M.tb exposure

Inclusion Criteria:

  • age less than 15 years
  • completion of informed consent

Exclusion Criteria:

  • less than 3 months of age
  • documented anemia
  • recent diagnosis of tuberculosis
  • receiving treatment for tuberculosis

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 identifier (NCT number): NCT00541294

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Contact: Anna M Mandalakas, MD, MS 001.216.844.3224
Contact: Anneke C Hesseling, MD, MS 011.27. 21.9389173

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South Africa
Despond TuTu TB Centre, Stellenbosch University Recruiting
Tygerberg, Western Cape, South Africa, 07505
Contact: Felcity Stevens    27219389772   
Contact: Grace Bruintjies    27219389631   
Principal Investigator: Anneke C Hesseling         
Sponsors and Collaborators
Case Western Reserve University
Thrasher Research Fund
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Principal Investigator: Anna M Mandalakas, MD, MS Case Western Reserve University
Principal Investigator: Anneke C Hesseling, MD, MS University of Stellenbosch
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Responsible Party: Anna Mandalakas/PI, Case Western Reserve University Identifier: NCT00541294    
Other Study ID Numbers: RES104272
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: August 3, 2010
Last Verified: August 2010
Keywords provided by Case Western Reserve University:
Additional relevant MeSH terms:
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Communicable Diseases
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections