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TB-CAPT CORE Truenat Trial

NCT04568954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3987

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Truenat TB platform/TB assays

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.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Centro de Investigação em Saúde de Manhiça

    collaborator OTHER

  • Instituto Nacional de Saúde, Mozambique

    collaborator OTHER_GOV

  • Ifakara Health Institute

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    lead OTHER

Principal Investigators

  • Katharina Kranzer · Medical Center of the University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-28
Primary Completion
2024-06-16
Completion
2024-12-31

Countries

  • Mozambique
  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04568954 on ClinicalTrials.gov