Improving Latent Tuberculosis (TB) Diagnosis 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.

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Key information

Conditions

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

Age range

2 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HIV Netherlands Australia Thailand (HIV-NAT) Research Organization, Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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 and collaborators

Lead sponsor

SEARCH Research Foundation

Other

Collaborators

Columbia University
HIV Netherlands Australia Thailand Research Collaboration
New York Blood Center
Queen Sirikit National Institute of Child Health

Registry information

Official study title

Improving the Diagnosis and Management of Latent Tuberculosis in Thai Children

Acronym: TB Px

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jul 28, 2009
Registry last updated: Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed