TB-CAPT CORE Truenat Trial

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04568954
• Other study ID #: TB041-3/1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 28, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 used as a strata variable in randomization process.

Facilities will be randomly allocated to the standard of care (control), or Truenat platform/TB assays (intervention).

A cluster refers to a clinic. The clusters will be assigned to intervention or control arm to one of two diagnostic procedures (SOC [smear microscopy and/or Xpert MTB/RIF Ultra off-site] vs Truenat platform/TB assays on-site) following a restricted randomization strategy, whereby 6 to 8 strata of clusters will be established using the stratification variables site (clinics belong to a site) and size and apply balance criteria for them. The number of strata per site depends on heterogeneity of the sizes of the clinics as established in setup period and may be increased, typically 1 or 2 strata per site will be established.

The primary endpoint will be compared in an individual level analysis with strata and intervention as fixed effects and cluster as random effect.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4200
• Est. completion date: April 30, 2024
• Est. primary completion date: January 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnoses Disease
• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
Mozambique	Centro de Investigação em Saúde de Manhiça-Fundação	Manhiça	Vila Da Manhiça
Mozambique	Instituto Nacional de Saúde (INS)	Maputo
Tanzania	Ifakara Health Institute	Dar es Salaam
Tanzania	National Institute of Medical Research (NIMR)	Mbeya

Sponsors (6)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Centro de Investigação em Saúde de Manhiça, Ifakara Health Institute, Instituto Nacional de Saúde, Mozambique, Ludwig-Maximilians - University of Munich, National Institute for Medical Research, Tanzania

Countries where clinical trial is conducted

Mozambique,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants	Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants	7 days
Secondary	Time to bacteriological confirmation of TB	Time to bacteriological confirmation of TB (up to 180 days) from enrolment	60 days
Secondary	Proportion of patients treated for TB up to 60 days from enrolment	Proportion of patients treated for TB up to 60 days from enrolment	60 days
Secondary	Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment	Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment	60 days
Secondary	Cost and productivity related endpoints	Patients' costs related to care at 60 days from enrolment.; Number of lost working days over the past month at 60 days from enrolment; Monthly earning in the past month at 60 days from enrolment	60 days