Improving Latent Tuberculosis (TB) Diagnosis in Thai Children

NCT00947609 | Completed

• 1 other identifier: SEARCH TB Px
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Latent Tuberculosis; HIV Infections

Keywords

Latent tuberculosis; HIV; Children; Interferon gamma release assays; Thailand; QuantiFERON TB Gold In-tube; T-Spot.TB

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Months - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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
• Are between the ages of 2 months and 16 years
• Parents or caregivers provide informed consent to participate
• Provide child assent for children aged ≥ 7 years

You may not qualify if:

• Child and/or parent/caregiver who refuse study participation
• Are currently receiving antituberculosis medications for TB disease
• Have recently been diagnosed with active TB within past 6 months

Sponsors & Collaborators

• SEARCH Research Foundation: lead
• Columbia University: collaborator
• New York Blood Center: collaborator
• HIV Netherlands Australia Thailand Research Collaboration: collaborator
• Queen Sirikit National Institute of Child Health: collaborator

Study Sites (2)

HIV Netherlands Australia Thailand (HIV-NAT) Research Organization

Bangkok, Thailand

Location

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

Location

MeSH Terms

Conditions

Latent Tuberculosis; HIV Infections

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

TH (2)