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.|
|ClinicalTrials.gov 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
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:
- assess the agreement between the TST and blood-based diagnostic testing,
- compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure,
- measure the impact of age, nutritional and immune status on children's response to blood-based testing,
- 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|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Diagnosis of Tuberculosis Infection in HIV Co-infected Children|
|Study Start Date :||October 2007|
|Estimated Study Completion Date :||September 2010|
M.tb unexposed HIV-infected and uninfected children <15 years of age
M.tb exposed HIV-infected and uninfected children <15 years of age
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 ClinicalTrials.gov identifier (NCT number): NCT00541294
|Contact: Anna M Mandalakas, MD, MSemail@example.com|
|Contact: Anneke C Hesseling, MD, MS||011.27. firstname.lastname@example.org|
|Despond TuTu TB Centre, Stellenbosch University||Recruiting|
|Tygerberg, Western Cape, South Africa, 07505|
|Contact: Felcity Stevens 27219389772 email@example.com|
|Contact: Grace Bruintjies 27219389631 firstname.lastname@example.org|
|Principal Investigator: Anneke C Hesseling|
|Principal Investigator:||Anna M Mandalakas, MD, MS||Case Western Reserve University|
|Principal Investigator:||Anneke C Hesseling, MD, MS||University of Stellenbosch|