Test and Treat to End Tuberculosis (TB): A screening and treatment study for children and adults with Latent Tuberculosis Infection (LTBI)

Phase 4

• Conditions: atent Tuberculosis Infection; tuberculosis; Latent Tuberculosis Infection; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases; Public Health - Epidemiology; Public Health - Health service research

• Registration Number: ACTRN12622000115730
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 208000

Inclusion Criteria

Eligibility criteria for TEST phase
1.Aged 5 years or older on the date of enumeration; AND
2.Capable of giving informed consent or, if aged < 15 years, having a parent or guardian who can give consent. Assent will also be routinely sought from children aged 10 to <15 years; AND
3.Not currently taking treatment for tuberculosis.
Eligibility criteria for TREAT phase
1.Meet eligibility criteria for testing and consented to screening; AND
2.Tuberculin skin test (TST) reaction size >= 10mm (or > 0mm if known to be HIV +ve) AND
3.Either no abnormality consistent with TB on chest radiograph OR abnormal radiograph but two sputum specimens are culture negative for M. tuberculosis

Exclusion Criteria

1. Pregnant or planning to be pregnant in next 6 months
2. Important potential drug interactions with the intervention regimen, defined by attending medical officer in accordance with a schedule.
3. Known allergy or hypersensitivity to the active substance or any of the ingredients of the study drugs
4. Has completed a course of treatment for TB within the preceding two years.
5. Serum transaminases (AST and ALT) are both >= 3 x upper limit of normal
6. Severe or life-threatening illness that is considered by the attending medical officer to make treatment for LTBI inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Population prevalence of bacteriologically-confirmed Tuberculosis (TB). This is will be estimated in a cross-survey of the general population aged 15 years and over. A bacteriologiically-confirmed case will be defined as a case in whom a sputum specimen tests positive on Xpert MTB Ultra (a nucleic acid amplification test) or on mycobacterial culture with subsequent identification as M tuberculosis. [A minimum of two years after commencement of the intervention]

Secondary Outcome Measures

Name	Time	Method
To estimate the incidence of severe adverse events attributable to the intervention. This will be assessed by clinical data review by an Expert Clinical Panel. They will have access to blood tests including liver function tests, [A minimum of two years after commencement of the intervention];To estimate the effect of the intervention on all-cause mortality;[A minimum of two years after commencement of the intervention];To estimate the prevalence of latent TB infection among children born between 2008 and 2016 this will be determined using the QuantiFERON®-TB Gold Plus test kit.<br>[A minimum of four years after commencement of the intervention]