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Improving Latent Tuberculosis (TB) Diagnosis in Thai Children

NCT00947609 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 158

Last updated 2012-06-06

No results posted yet for this study

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

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • New York Blood Center

    collaborator OTHER

  • HIV Netherlands Australia Thailand Research Collaboration

    collaborator NETWORK

  • Queen Sirikit National Institute of Child Health

    collaborator OTHER_GOV

  • SEARCH Research Foundation

    lead OTHER

Principal Investigators

  • Jintanat Ananworanich, MD, PhD · South East Asia Research Collaboration with Hawaii, HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand

  • Piyarat Suntarattiwong, MD · Queen Sirikit National Institute of Child Health, Bangkok, Thailand

  • Simon Tsiouris, MD, MPH · Columbia University

Eligibility

Min Age
2 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Thailand

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947609 on ClinicalTrials.gov