Latent TuberculosisTB PxNCT00947609
Improving Latent Tuberculosis (TB) Diagnosis in Thai Children
An observational study of Latent Tuberculosis and HIV Infections, run by SEARCH Research Foundation at 2 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis, HIV Infections
- How many people
- 158 participants
- Where
- 2 sitesThailand
- Study dates
- Aug 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
HIV Netherlands Australia Thailand (HIV-NAT) Research Organization
Bangkok
Queen Sirikit National Institute of Child Health
Bangkok
About this study
Official title: Improving the Diagnosis and Management of Latent Tuberculosis 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.
Read the 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.
- Conditions
- Latent Tuberculosis, HIV Infections
- Keywords
- Latent tuberculosis, HIV, Children, Interferon gamma release assays, Thailand, QuantiFERON TB Gold In-tube, T-Spot.TB
- Medical subject headings
- Latent Tuberculosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEARCH Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, New York Blood Center, HIV Netherlands Australia Thailand Research Collaboration, Queen Sirikit National Institute of Child Health
- Responsible party
- Principal investigator, Hong Van Tieu, Columbia University
- Investigators
- Jintanat Ananworanich, MD, PhD, Principal investigator, South East Asia Research Collaboration with Hawaii, HIV Netherlands Australia Thailand Research Collaboration, Bangkok, ThailandPiyarat Suntarattiwong, MD, Principal investigator, Queen Sirikit National Institute of Child Health, Bangkok, ThailandSimon Tsiouris, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947609
- Sponsor's protocol ID
- SEARCH TB Px
- Acronym
- TB Px
- Status last verified
- Jun 2012
- First submitted
- 27 Jul 2009
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Diagnosis and Management of Latent Tuberculosis in Thai Children
- ClinicalTrials.gov ID
- NCT00947609
- Acronym / sponsor ID
- TB Px / SEARCH TB Px
- Conditions
- Latent Tuberculosis, HIV Infections
- Keywords
- Latent tuberculosis, HIV, Children, Interferon gamma release assays, Thailand, QuantiFERON TB Gold In-tube, T-Spot.TB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- SEARCH Research FoundationUniversity, hospital or other
- Collaborators
- Columbia University, New York Blood Center, HIV Netherlands Australia Thailand Research Collaboration, Queen Sirikit National Institute of Child Health
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jintanat Ananworanich, MD, PhD principal investigator
South East Asia Research Collaboration with Hawaii, HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand
Piyarat Suntarattiwong, MD principal investigator
Queen Sirikit National Institute of Child Health, Bangkok, Thailand
Simon Tsiouris, MD, MPH principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Latent Tuberculosis and HIV Infections, run by SEARCH Research Foundation at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.