Improving Latent Tuberculosis (TB) Diagnosis in Thai Children (TB Px)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Improving the Diagnosis and Management of Latent Tuberculosis in Thai Children|
|Study Start Date:||August 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
- 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
What is the sensitivity and specificity of IGRAs and TST in screening for latent TB in HIV-infected and HIV uninfected children in Thailand?
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947609
|HIV Netherlands Australia Thailand (HIV-NAT) Research Organization|
|Queen Sirikit National Institute of Child Health|
|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|