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Improving Latent Tuberculosis (TB) Diagnosis in Thai Children (TB Px)

This study has been completed.
Sponsor:
Collaborators:
Columbia University
New York Blood Center
HIV Netherlands Australia Thailand Research Collaboration
Queen Sirikit National Institute of Child Health
Information provided by (Responsible Party):
Hong Van Tieu, Columbia University
ClinicalTrials.gov Identifier:
NCT00947609
First received: July 27, 2009
Last updated: June 5, 2012
Last verified: June 2012
History of Changes

July 27, 2009
June 5, 2012
August 2009
December 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00947609 on ClinicalTrials.gov Archive Site
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Improving Latent Tuberculosis (TB) Diagnosis in Thai Children
Improving the Diagnosis and Management of Latent Tuberculosis in Thai Children

The study is a prospective study to improve the diagnosis and management of latent TB in HIV-infected and HIV uninfected children in Thailand. The objectives are to assess the sensitivity and specificity of IGRAs (T-Spot®.TB, a T-cell-based assay, and QuantiFERON®-TB Gold In-tube, a whole blood assay), TST, and a refined symptom-based questionnaire in diagnosing latent TB in 166 HIV-infected and HIV uninfected children in Thailand, and to evaluate the influence of age, nutritional and immune status on children's response to the IGRAs. These children will be screened for TB with a detailed TB contact history, symptom-based questionnaire, physical examination, TST, chest radiograph (and abdominal ultrasound for those with abdominal symptoms), IGRAs, and clinical specimens for acid fast bacilli stain and culture. A diagnostic algorithm will be generated using the combination of test modalities with the highest sensitivity and specificity results.

Study Objectives

  • To compare the utility of IGRAs, T-Spot®.TB and QuantiFERON®-TB Gold In-Tube, and TST for screening of latent TB in HIV-infected children
  • To compare these different screening modalities in HIV-infected children to HIV uninfected children
  • To assess the influence of age, nutritional and immune status, prior BCG and TST status on children's response to IGRAs
  • To assess the prognostic value of IGRAs vs. TST in predicting development of active TB in children over 9 months

Research questions:

Primary:

What is the sensitivity and specificity of IGRAs and TST in screening for latent TB in HIV-infected and HIV uninfected children in Thailand?

Secondary:

How do age, nutritional and immune status, prior BCG and PPD status influence children's response to IGRAs? What is the prognostic value of IGRAs vs. TST in predicting development of active TB in children over 9 months?

This is a prospective cohort study conducted at two sites in Bangkok, Thailand: HIV Netherlands Australia Thailand (HIV-NAT) Clinic/Chulalongkorn Hospital and Queen Sirikit National Institute of Child Health.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Thai children between the ages of 2 months and 16 years with exposure to active TB adult cases will be referred to the two study sites for eligibility screening.
  • Latent Tuberculosis
  • HIV Infections
Not Provided
HIV-infected and HIV-uninfected children
HIV-infected and HIV uninfected children with recent exposure to adults with active tuberculosis will be referred to the two study sites (HIV-NAT/Chulalongkorn and Queen Sirikit) for eligibility screening and enrollment in the study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have close contact with a person > 15 years of age who had active pulmonary (± extrapulmonary), sputum AFB positive TB (household member or non-household member with contact > 120 hours/month) during the past year
  2. Are between the ages of 2 months and 16 years
  3. Parents or caregivers provide informed consent to participate
  4. Provide child assent for children aged ≥ 7 years

Exclusion Criteria:

  1. Child and/or parent/caregiver who refuse study participation
  2. Are currently receiving antituberculosis medications for TB disease
  3. Have recently been diagnosed with active TB within past 6 months
Both
2 Months to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00947609
SEARCH TB Px
No
Hong Van Tieu, Columbia University
South East Asia Research Collaboration with Hawaii
  • Columbia University
  • New York Blood Center
  • HIV Netherlands Australia Thailand Research Collaboration
  • Queen Sirikit National Institute of Child Health
Principal Investigator: Jintanat Ananworanich, MD, PhD South East Asia Research Collaboration with Hawaii, HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand
Principal Investigator: Piyarat Suntarattiwong, MD Queen Sirikit National Institute of Child Health, Bangkok, Thailand
Principal Investigator: Simon Tsiouris, MD, MPH Columbia University
South East Asia Research Collaboration with Hawaii
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP