CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,987 enrolled
Drug / intervention
Truenat TB platform/TB assaysother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04568954
NCT04568954N/ACompleted
CompareCT.gov

Molbio Truenat TB Platform Combined With the Truenat TB Assays for Detection of Tuberculosis and Rifampicin Resistance in Adults With Presumptive Pulmonary Tuberculosis at Primary-level Diagnostic Centres in Tanzania and Mozambique: a Pragmatic, Cluster-randomized Controlled Trial

Foundation for Innovative New Diagnostics, Switzerland·interventional·Posted Sep 29, 2020·Updated Apr 4, 2025

In Brief

A clinical study evaluating Truenat TB platform/TB assays for Tuberculosis and Diagnoses Disease. Completed, enrolled 3,987 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Diagnoses Disease
CountriesMozambique, Tanzania
CollaboratorsLudwig-Maximilians - University of Munich, National Institute for Medical Research, Tanzania, Centro de Investigação em Saúde de Manhiça, Instituto Nacional de Saúde, Mozambique, Ifakara Health Institute

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 29, 2020
Enrollment StartAug 28, 2022
Primary CompletionJun 16, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.8 years ago

Interventions

Truenat TB platform/TB assaysother

Truenat TB platform/TB assays, a molecular diagnostic test developed by Molbio diagnostics, for the diagnosis of Mycobacterium tuberculosis complex (MTBC) and Truenat MTB-RIF Dx for detection of RIF resistance was endorsed in 2020 by the WHO for TB diagnosis. The system has been designed to be operated as a point-of-care- diagnostic solution in peripheral laboratories with minimal infrastructure. It takes about 25 minutes to do the DNA extraction and another 35 minutes to diagnose TB. It is portable and battery operated, have no need for a computer or laptop, and operate from 2-40 C ambient temperature. The system uses room temperature stable reagents with long shelf life.