TB-CAPT CORE Truenat Trial
Primary Purpose
Tuberculosis, Diagnoses Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Truenat TB platform/TB assays
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis
Eligibility Criteria
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
Sites / Locations
- Centro de Investigação em Saúde de Manhiça-FundaçãoRecruiting
- Instituto Nacional de Saúde (INS)Recruiting
- Ifakara Health InstituteRecruiting
- National Institute of Medical Research (NIMR)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TB testing using the Truenat platform/TB assays
Standard of care Arm
Arm Description
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
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to bacteriological confirmation of TB
Time to bacteriological confirmation of TB (up to 180 days) from enrolment
Proportion of patients treated for TB up to 60 days from enrolment
Proportion of patients treated for TB up to 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
Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
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
Full Information
NCT ID
NCT04568954
First Posted
September 23, 2020
Last Updated
November 30, 2022
Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Ludwig-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
1. Study Identification
Unique Protocol Identification Number
NCT04568954
Brief Title
TB-CAPT CORE Truenat 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2022 (Actual)
Primary Completion Date
January 28, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Ludwig-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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Diagnoses Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The objective of the trial is to assess Truenat platform/TB assays in clinical care. The use of Truenat platform/TB assays does not allow blinding of clinicians and participants in this trial. The trial-related procedures will be embedded into the routine practice at the primary-level facility. Data analysts will be blinded to intervention allocation.
Randomisation takes place on a cluster level rather than for the individual patients to avoid contamination between the arms within a health facility. Since clinics will be relatively far apart, contamination is unlikely.
Allocation
Randomized
Enrollment
4200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TB testing using the Truenat platform/TB assays
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of care Arm
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Truenat TB platform/TB assays
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
Description
Proportion of participants with microbiological confirmation starting TB treatment within 7 days of their first visit among enrolled participants
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Time to bacteriological confirmation of TB
Description
Time to bacteriological confirmation of TB (up to 180 days) from enrolment
Time Frame
60 days
Title
Proportion of patients treated for TB up to 60 days from enrolment
Description
Proportion of patients treated for TB up to 60 days from enrolment
Time Frame
60 days
Title
Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
Description
Proportion of participants with signs and symptoms suggestive of pulmonary TB starting TB treatment with microbiological confirmation within 60 days from enrolment
Time Frame
60 days
Title
Cost and productivity related endpoints
Description
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
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Penn-Nicholson, PhD
Phone
+41 22 710 05 91
Email
Adam.Penn-Nicholson@finddx.org
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Ruhwald, MD, PhD
Phone
+41 22 710 05 91
Email
Morten.Ruhwald@finddx.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina Kranzer
Organizational Affiliation
Medical Center of the University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigação em Saúde de Manhiça-Fundação
City
Manhiça
State/Province
Vila Da Manhiça
ZIP/Postal Code
1929
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinis Nguenha, MD, MSC
Phone
+258 21 81 00 02/181
Email
dinis.nguenha@manhica.net
Facility Name
Instituto Nacional de Saúde (INS)
City
Maputo
ZIP/Postal Code
1100
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celso Khosa, MD, PhD
Phone
+258 21431103
Email
celso.khosa@ins.gov.mz
Facility Name
Ifakara Health Institute
City
Dar es Salaam
ZIP/Postal Code
Box 78 373
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Hella, MD
Phone
+255 713 787 754
Email
jhella@ihi.or.tz
First Name & Middle Initial & Last Name & Degree
Klaus Reither, MD
Phone
+41 61284 8967
Email
Klaus.Reither@swisstph.ch
Facility Name
National Institute of Medical Research (NIMR)
City
Mbeya
ZIP/Postal Code
2410
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nyanda Ntinginya, MD, PhD
Phone
+255 25 2503364
Email
nelias@nimr-mmrc.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Upon publication of the main study manuscript
Learn more about this trial
TB-CAPT CORE Truenat Trial
We'll reach out to this number within 24 hrs