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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Case Western Reserve University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00541294
First received: October 5, 2007
Last updated: August 2, 2010
Last verified: August 2010

October 5, 2007
August 2, 2010
October 2007
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Complete list of historical versions of study NCT00541294 on ClinicalTrials.gov Archive Site
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Diagnosis of Tuberculosis Infection in HIV Co-infected Children
Diagnosis of Tuberculosis Infection in HIV Co-infected Children

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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

HIV seropositive and seronegative South African children (6months to 15years) with and without M.tb exposure

  • Latent Tuberculosis Infection
  • Tuberculosis
  • HIV Infections
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  • B
    M.tb unexposed HIV-infected and uninfected children <15 years of age
  • A
    M.tb exposed HIV-infected and uninfected children <15 years of age
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
September 2010
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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
Both
3 Months to 15 Years
No
Contact: Anna M Mandalakas, MD, MS 001.216.844.3224 anna.mandalakas@case.edu
Contact: Anneke C Hesseling, MD, MS 011.27. 21.9389173 annekeh@sun.ac.za
South Africa
 
NCT00541294
RES104272
No
Anna Mandalakas/PI, Case Western Reserve University
Case Western Reserve University
Thrasher Research Fund
Principal Investigator: Anna M Mandalakas, MD, MS Case Western Reserve University
Principal Investigator: Anneke C Hesseling, MD, MS University of Stellenbosch
Case Western Reserve University
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP