Diagnosis of Tuberculosis Infection in HIV Co-infected Children
Information source: Case Western Reserve University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Latent Tuberculosis Infection; Tuberculosis; HIV Infections
Phase: N/A
Status: Recruiting
Sponsored by: Case Western Reserve University Official(s) and/or principal investigator(s): Anna M Mandalakas, MD, MS, Principal Investigator, Affiliation: Case Western Reserve University Anneke C Hesseling, MD, MS, Principal Investigator, Affiliation: University of Stellenbosch
Overall contact: Anna M Mandalakas, MD, MS, Phone: 001.216.844.3224, Email: anna.mandalakas@case.edu
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.
Clinical Details
Official title: Diagnosis of Tuberculosis Infection in HIV Co-infected Children
Study design: Time Perspective: Prospective
Eligibility
Minimum age: 3 Months.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Anna M Mandalakas, MD, MS, Phone: 001.216.844.3224, Email: anna.mandalakas@case.edu
Despond TuTu TB Centre, Stellenbosch University, Tygerberg, Western Cape 07505, South Africa; Recruiting Felcity Stevens, Phone: 27219389772, Email: felicity@sun.ac.za Grace Bruintjies, Phone: 27219389631, Email: graceb@sun.ac.za Anneke C Hesseling, Principal Investigator
Additional Information
Starting date: October 2007
Last updated: August 2, 2010
|