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

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 Overview

• Status: Completed
• Conditions: HIV Infections; Latent Tuberculosis

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.

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • HIV Netherlands Australia Thailand (HIV-NAT) Research Organization
  • Bangkok, Thailand
    • Queen Sirikit National Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

• Sponsor: South East Asia Research Collaboration with Hawaii
• Collaborators: Columbia University; Queen Sirikit National Institute of Child Health; New York Blood Center; HIV Netherlands Australia Thailand Research Collaboration
• 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

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 27, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimate): July 28, 2009

Study Record Updates

• Last Update Posted (Estimate): June 6, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: HIV; Children; Thailand; Latent tuberculosis; Interferon gamma release assays; QuantiFERON TB Gold In-tube; T-Spot.TB
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: SEARCH TB Px