ACTRN12622000115730
Not yet recruiting
Phase 4
Test and Treat to End Tuberculosis (TB): Investigating the effect of a screening for, and treatment of, latent TB infection (LTBI) in the general population on the prevalence of TB in that population.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- atent Tuberculosis Infection
- Sponsor
- Woolcock Institute of Medical Research
- Enrollment
- 208000
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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