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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00541294
Other study ID # RES104272
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2008
Est. completion date February 22, 2011

Study information

Verified date January 2022
Source Case Western Reserve University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date February 22, 2011
Est. primary completion date February 22, 2011
Accepts healthy volunteers No
Gender All
Age group 3 Months to 15 Years
Eligibility 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

Study Design


Locations

Country Name City State
South Africa Despond TuTu TB Centre, Stellenbosch University Tygerberg Western Cape

Sponsors (2)

Lead Sponsor Collaborator
Case Western Reserve University Thrasher Research Fund

Country where clinical trial is conducted

South Africa, 

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