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
  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:

  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.


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

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

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
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541294

Contacts
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

Locations
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         
Sponsors and Collaborators
Case Western Reserve University
Thrasher Research Fund
Investigators
Principal Investigator: Anna M Mandalakas, MD, MS Case Western Reserve University
Principal Investigator: Anneke C Hesseling, MD, MS University of Stellenbosch
  More Information

No publications provided

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

Keywords provided by Case Western Reserve University:
Tuberculosis
HIV
Diagnostics
Pediatrics

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 31, 2014