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
  Purpose

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.


Condition
Latent Tuberculosis
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving the Diagnosis and Management of Latent Tuberculosis in Thai Children

Resource links provided by NLM:


Further study details as provided by South East Asia Research Collaboration with Hawaii:

Enrollment: 158
Study Start Date: August 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  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: NCT00947609

Locations
Thailand
HIV Netherlands Australia Thailand (HIV-NAT) Research Organization
Bangkok, Thailand
Queen Sirikit National Institute of Child Health
Bangkok, Thailand
Sponsors and Collaborators
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
Investigators
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
  More Information

No publications provided

Responsible Party: Hong Van Tieu, Co-investigator, Columbia University
ClinicalTrials.gov Identifier: NCT00947609     History of Changes
Other Study ID Numbers: SEARCH TB Px
Study First Received: July 27, 2009
Last Updated: June 5, 2012
Health Authority: Thailand: Ministry of Public Health
United States: Institutional Review Board

Keywords provided by South East Asia Research Collaboration with Hawaii:
Latent tuberculosis
HIV
Children
Interferon gamma release assays
Thailand
QuantiFERON TB Gold In-tube
T-Spot.TB

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 August 20, 2014