Clinical trial NCT00947609: Improving Latent Tuberculosis (TB) Diagnosis in Thai Children
Official title: Improving the Diagnosis and Management of Latent Tuberculosis in Thai Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Latent Tuberculosis
HIV Infections
Keywords: Latent tuberculosis
HIV
Children
Interferon gamma release assays
Thailand
QuantiFERON TB Gold In-tube
T-Spot.TB
Lead sponsor: SEARCH Research Foundation
Sponsor class: OTHER
Collaborators: name: Columbia University
name: New York Blood Center
name: HIV Netherlands Australia Thailand Research Collaboration
name: Queen Sirikit National Institute of Child Health
First posted: 2009-07-28
Enrollment: 158
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Are between the ages of 2 months and 16 years
3. Parents or caregivers provide informed consent to participate
4. Provide child assent for children aged ≥ 7 years

Exclusion Criteria:

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV Netherlands Australia Thailand (HIV-NAT) Research Organization
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
Study officials:
affiliation: South East Asia Research Collaboration with Hawaii, HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand
name: Jintanat Ananworanich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Sirikit National Institute of Child Health, Bangkok, Thailand
name: Piyarat Suntarattiwong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Simon Tsiouris, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: