Latent Tuberculosis InfectionThrasherIGRANCT00541294
Diagnosis of Tuberculosis Infection in HIV Co-infected Children
An observational study of Latent Tuberculosis Infection and Tuberculosis, run by Case Western Reserve University at 1 site in South Africa.
Trial summary
Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival. Read more about this study
- Who is it for?
- Ages 3 months to 15 years
- Conditions the study is for
- Latent Tuberculosis Infection, Tuberculosis, HIV Infections
- How many people
- 250 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Jan 2008to 22 Feb 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 3 months to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: HIV seropositive and seronegative South African children (6months to 15years) with and without M.tb exposure
Who may be able to join
- age less than 15 years
- completion of informed consent
Who cannot join
- less than 3 months of age
- documented anemia
- recent diagnosis of tuberculosis
- receiving treatment for tuberculosis
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Despond TuTu TB Centre, Stellenbosch University
Tygerberg, Western Cape, 07505
About this study
Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival.
The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited.
Read more
Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic testing can accurately identify children with TB infection. In a community with high rates of TB and HIV infection, the following specific aims will be investigated in HIV-infected and uninfected children:
- assess the agreement between the TST and blood-based diagnostic testing,
- compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure,
- measure the impact of age, nutritional and immune status on children's response to blood-based testing,
- describe factors that might modify children's response to testing over time, and 5) examine the effect of environmental exposures and previous vaccination on the TST, blood-based testing and other measures of immune responses to TB.
Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in children include 1) timely institution of treatment for TB infection to prevent severe disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of childhood TB infection also prevents future contagious adult disease, thus decreasing community transmission. Blood-based diagnostic testing may also be able to identify children that are more likely to become ill following TB infection. Therefore, blood-based diagnostic testing has great potential to improve TB control and the health of HIV-infected and uninfected children, their households and communities.
- Conditions
- Latent Tuberculosis Infection, Tuberculosis, HIV Infections
- Keywords
- Tuberculosis, HIV, Diagnostics, Pediatrics
- Medical subject headings
- Latent Tuberculosis, 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 |
|---|---|---|
| B | M.tb unexposed HIV-infected and uninfected children <15 years of age | |
| A | M.tb exposed HIV-infected and uninfected children <15 years of age |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study start15 Jan 2008
- Primary completion22 Feb 2011
- Study completion22 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Tuberculosis InfectionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Anna Maria Mandalakas, Baylor College of Medicine
- Investigators
- Anna M Mandalakas, MD, PhD, Principal investigator, Baylor College of MedicineAnneke C Hesseling, MD, MS, Principal investigator, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541294
- Sponsor's protocol ID
- RES104272
- Acronym
- ThrasherIGRA
- Status last verified
- Jan 2022
- First submitted
- 5 Oct 2007
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Tuberculosis Infection in HIV Co-infected Children
- ClinicalTrials.gov ID
- NCT00541294
- Acronym / sponsor ID
- ThrasherIGRA / RES104272
- Conditions
- Latent Tuberculosis Infection, Tuberculosis, HIV Infections
- Keywords
- Tuberculosis, HIV, Diagnostics, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 15 Jan 2008 (actual)
- Primary completion
- 22 Feb 2011 (actual)
- Study completion
- 22 Feb 2011 (actual)
- First posted
- 10 Oct 2007 (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.
Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival.
The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited.
Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic testing can accurately identify children with TB infection. In a community with high rates of TB and HIV infection, the following specific aims will be investigated in HIV-infected and uninfected children:
- assess the agreement between the TST and blood-based diagnostic testing,
- compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure,
- measure the impact of age, nutritional and immune status on children's response to blood-based testing,
- describe factors that might modify children's response to testing over time, and 5) examine the effect of environmental exposures and previous vaccination on the TST, blood-based testing and other measures of immune responses to TB.
Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in children include 1) timely institution of treatment for TB infection to prevent severe disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of childhood TB infection also prevents future contagious adult disease, thus decreasing community transmission. Blood-based diagnostic testing may also be able to identify children that are more likely to become ill following TB infection. Therefore, blood-based diagnostic testing has great potential to improve TB control and the health of HIV-infected and uninfected children, their households and communities.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | – | –M.tb unexposed HIV-infected and uninfected children <15 years of age |
| A | – | –M.tb exposed HIV-infected and uninfected children <15 years of age |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- HIV seropositive and seronegative South African children (6months to 15years) with and without M.tb exposure
Key inclusion criteria (2 listed)
- age less than 15 years
- completion of informed consent
Key exclusion criteria (4 listed)
- less than 3 months of age
- documented anemia
- recent diagnosis of tuberculosis
- receiving treatment for tuberculosis
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 18 Jan 2022.
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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.
Anna M Mandalakas, MD, PhD principal investigator
Baylor College of Medicine
Anneke C Hesseling, MD, MS principal investigator
University of Stellenbosch
1 site 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 Infection and Tuberculosis, run by Case Western Reserve University at 1 site in South Africa.
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 2 inclusion and 4 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 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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 18 Jan 2022.