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| Sponsor: | South East Asia Research Collaboration with Hawaii |
|---|---|
| Collaborators: |
Columbia University New York Blood Center HIV Netherlands Australia Thailand Research Collaboration Queen Sirikit National Institute of Child Health |
| Information provided by: | South East Asia Research Collaboration with Hawaii |
| ClinicalTrials.gov Identifier: | NCT00947609 |
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 |
|---|
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Latent Tuberculosis HIV Infections |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Improving the Diagnosis and Management of Latent Tuberculosis in Thai Children |
| Estimated Enrollment: | 166 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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.
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Study Objectives
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 |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Thailand | |
| HIV Netherlands Australia Thailand (HIV-NAT) Research Organization | |
| Bangkok, Thailand | |
| Queen Sirikit National Institute of Child Health | |
| Bangkok, Thailand | |
| 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
| Responsible Party: | South East Asia Research Collaboration with Hawaii ( Jintanat Ananworanich, MD, PhD, Chief ) |
| Study ID Numbers: | SEARCH TB Px |
| Study First Received: | July 27, 2009 |
| Last Updated: | July 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00947609 History of Changes |
| Health Authority: | Thailand: Ministry of Public Health; United States: Institutional Review Board |
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Latent tuberculosis HIV Children Interferon gamma release assays |
Thailand QuantiFERON TB Gold In-tube T-Spot.TB |
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Bacterial Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Actinomycetales Infections Immunologic Deficiency Syndromes |
Virus Diseases Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections Tuberculosis Retroviridae Infections |
