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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04568954




Registration number
NCT04568954
Ethics application status
Date submitted
23/09/2020
Date registered
29/09/2020

Titles & IDs
Public title
TB-CAPT CORE Truenat Trial
Scientific 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
Secondary ID [1] 0 0
TB041-3/1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 0 0
Diagnoses Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Truenat TB platform/TB assays

Experimental: TB testing using the Truenat platform/TB assays - TB testing using the Truenat platform/TB assays placed at primary health care clinics combined with rapid communication of results and same day TB treatment initiation

No intervention: Standard of care Arm - Standard of care for TB testing using a combination of smear microscopy and laboratory (off-site) Xpert testing, may vary by clinic depending on availability of transport and stock of Xpert MTB/RIF or Xpert MTB/RIF Ultra cartridges (Xpert).


Diagnosis / Prognosis: 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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Time to bacteriological confirmation of TB
Timepoint [1] 0 0
60 days
Secondary outcome [2] 0 0
Proportion of patients treated for TB up to 60 days from enrolment
Timepoint [2] 0 0
60 days
Secondary outcome [3] 0 0
Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
Timepoint [3] 0 0
60 days
Secondary outcome [4] 0 0
Cost and productivity related endpoints
Timepoint [4] 0 0
60 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
3987
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Mozambique
State/province [1] 0 0
Vila Da Manhiça
Country [2] 0 0
Mozambique
State/province [2] 0 0
Maputo
Country [3] 0 0
Tanzania
State/province [3] 0 0
Dar es Salaam
Country [4] 0 0
Tanzania
State/province [4] 0 0
Mbeya

Funding & Sponsors
Primary sponsor type
Other
Name
Foundation for Innovative New Diagnostics, Switzerland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Ludwig-Maximilians - University of Munich
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Institute for Medical Research, Tanzania
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Centro de Investigação em Saúde de Manhiça
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Instituto Nacional de Saúde, Mozambique
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Ifakara Health Institute
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Katharina Kranzer
Address 0 0
Medical Center of the University of Munich
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual, de-identified participant data may be shared, including data dictionaries. Available documents include the study protocol and statistical analysis plan. Templates of the informed consent forms may be shared upon request. The data will be available immediately following publication with no end date, will be shared with anyone who wishes to access them, and will be available for any purpose of analyses.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
Upon publication of the main study manuscript
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04568954