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| Sponsor: | Case Western Reserve University |
|---|---|
| Collaborator: |
Thrasher Research Fund |
| Information provided by: | Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT00541294 |
Purpose
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:
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 |
|---|
|
Latent Tuberculosis Infection Tuberculosis HIV Infections |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Diagnosis of Tuberculosis Infection in HIV Co-infected Children |
| Estimated Enrollment: | 250 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | September 2010 |
| Groups/Cohorts |
|---|
|
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
|
Eligibility| Ages Eligible for Study: | 3 Months to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
HIV seropositive and seronegative South African children (6months to 15years) with and without M.tb exposure
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| Despond TuTu TB Centre, Stellenbosch University | Recruiting |
| Tygerberg, Western Cape, South Africa, 07505 | |
| Contact: Felcity Stevens 27219389772 felicity@sun.ac.za | |
| Contact: Grace Bruintjies 27219389631 graceb@sun.ac.za | |
| Principal Investigator: Anneke C Hesseling | |
| Principal Investigator: | Anna M Mandalakas, MD, MS | Case Western Reserve University |
| Principal Investigator: | Anneke C Hesseling, MD, MS | Stellenbosch University |
More Information
| Responsible Party: | Anna Mandalakas/PI, Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT00541294 History of Changes |
| Other Study ID Numbers: | RES104272 |
| Study First Received: | October 5, 2007 |
| Last Updated: | August 2, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Tuberculosis HIV Diagnostics Pediatrics |
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Latent Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |