TB-CAPT CORE Truenat Trial

Launched by FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS, SWITZERLAND · Sep 28, 2020

Keywords

ClinConnect Summary

A cluster randomized controlled trial to evaluate the effect of placing Truenat platform/TB assays at primary health care clinics combined with rapid communication of results on time to treatment initiation of microbiologically confirmed TB.

In a setup period (survey of study centers) before randomization, the healthcare facilities (=clinics) of 4 sites will be asked to provide information about the number of TB notifications per quarter covering the period 1/2018-6/2020. From this information the foreseeable number of examined patients ("size of a clinic") will be derived, which will be u...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with presumptive pulmonary TB, as defined by the national TB treatment guidelines in each country: patients with cough more than 1-2 weeks and/or fever, night sweats, blood-stained sputum (haemoptysis) significant weight loss, abnormalities on chest radiograph
• • Adults 18 years old and above who are able and willing to consent
• Exclusion Criteria:
• • Circumstances that raise doubt on free, informed consent (e.g. in a mentally impaired person or a prisoner)
• • Already diagnosed with TB
• • Currently receiving anti-TB therapy
• • Patients with symptoms which are only attributable to extra-pulmonary TB
• • Patients who are seriously ill and need to be admitted to hospital