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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04568954
Other study ID # TB041-3/1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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