TuberculosisNCT04147676
Evaluation of Centralised TB Assay Solutions
An observational study of Tuberculosis and Drug-resistant Tuberculosis, run by Foundation for Innovative New Diagnostics, Switzerland at 6 sites in 5 countries.
Trial summary
Tuberculosis (TB) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant TB. Diagnostic based on culture and conventional drug susceptibility testing using media take several weeks leading to prolonged periods of ineffective therapy and ongoing transmission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Drug-resistant Tuberculosis
- How many people
- 1,050 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 20 May 2019to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in whom pulmonary TB is suspected. Additionally, well-characterized RIF-resistant and INH-resistant samples will be used to supplement drug-resistant cases.
Who may be able to join
- Patients are eligible to be included as trial participants only if all of the following inclusion criteria apply:
- Aged ≥18 years
- Clinical suspicion of pulmonary TB including cough ≥2 weeks (or any duration if HIV positive ) and ≥1 other symptom typical of pulmonary TB listed below:
- Fever
- Malaise
- Recent weight loss
Show all 11Show fewer
- Night sweats
- Contact with active case
- Haemoptysis
- Chest pain
- Loss of appetite
Who cannot join
- Participants are excluded from the trial if any of the following exclusion criteria apply:
- Unwilling or unable to provide informed consent
- Unwilling to provide four sputum specimens at enrolment i.e. 2x sputa on day 1 and 2x sputa on day 2 (up to 1 week from enrolment)
- Patients with only extra-pulmonary TB signs \& symptoms
- Receipt of any dose of TB treatment within 6 months prior to enrolment
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
India2 sites
Indian Council of Medical Research (ICMR) Regional Medical Research Centre
Bhubaneswar, 751023
National Institute for Research in Tuberculosis
Chennai, 600031
Germany1 site
Forschungszentrum Borstel. Leibniz Lungenzentrum (Borstel)
Borstel, 23845
Moldova1 site
Institute of Phthisiopneumology "Ch. Draganiuc" (PPI NRL), Moldova
Chisinau, 2025
South Africa1 site
Division of Wits Health Consortium (DMMH)
Johannesburg, 2193
About this study
Official title: Multicentre Trial to Assess the Performance of Centralized Assay Solutions for Detection of MTB and Resistance to Rifampin and Isoniazid
Tuberculosis (TB) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant TB. Diagnostic based on culture and conventional drug susceptibility testing using media take several weeks leading to prolonged periods of ineffective therapy and ongoing transmission. Development of rapid molecular diagnostic tests for the identification of Mycobacterium tuberculosis (MTB) and drug resistance has become a high priority.
The Xpert® MTB/RIF Assay does not provide information on INH-resistance and the LPA is only recommended for use in smear-positive samples, complex to perform and requires manual interpretation. Several novel assays have been recently developed/CE-marked offering high sample throughput and higher sensitivity for detection of MTB, RIF- and INH-resistance in centralized laboratories. However, published data on their performance and operational characteristics is extremely limited.
Read more
This is a prospective, multicentre, diagnostic accuracy trial in which the performance of centralised TB assay solutions will be assessed at the intended setting of use with culture, phenotypic DST and sequencing as reference standard.
Potential trial participants will be identified at participating TB clinics or hospitals (enrolment sites). Sputum samples will be collected and transported to the associated TB reference laboratories (testing sites).
In order for the results of this trial to be generalizable, adults with symptoms compatible with pulmonary TB undergoing evaluation will be screened for inclusion at geographically diverse participating centres in high burden TB countries. Additionally, to supplement the drug-resistant cases to timely achieve accurate performance estimates, well-characterized frozen sputum samples from the FIND specimen bank will be used.
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis
- Medical subject headings
- Tuberculosis, Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TB suspects | Sputum specimens will be collected from TB suspects enrolled in the study. The specimens will be tested with 1. Roche cobas MTB - for the detection of Mycobacterium tuberculosis complex 2. Roche cobas MTB-RIF/INH - all specimens that are Mycobacterium tuberculosis complex positive will be reflexed to the Roche cobas MTB-RIF/INH test for the detection of resistance to rifampicin and isoniazid 3. Hain FluoroType MTBDR - for the detection of Mycobacterium tuberculosis complex and the detection of resistance to rifampicin and isoniazid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy for MTB detection
clinical sensitivity and specificity by smear-status measured against mycobacterial culture as the reference standard.
Measured: four to six months
Diagnostic accuracy for RIF/INH detection
clinical point estimates of sensitivity and specificity measured against a composite reference standard of phenotypic DST and targeted sequencing.
Measured: four to six months
Secondary outcomes (1)
Operational characteristics:
description of operator experience with the assays through daily observed usage and user appraisal questionnaires.
Measured: four to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start20 May 2019
- Primary completion17 Apr 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147676
- Sponsor's protocol ID
- 7213-2/1
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Trial to Assess the Performance of Centralized Assay Solutions for Detection of MTB and Resistance to Rifampin and Isoniazid
- ClinicalTrials.gov ID
- NCT04147676
- Acronym / sponsor ID
- 7213-2/1
- Conditions
- Tuberculosis, Drug-resistant Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tuberculosis (TB) remains a life-threatening disease partly due to increasing incidence of multidrug and extensively drug-resistant TB. Diagnostic based on culture and conventional drug susceptibility testing using media take several weeks leading to prolonged periods of ineffective therapy and ongoing transmission. Development of rapid molecular diagnostic tests for the identification of Mycobacterium tuberculosis (MTB) and drug resistance has become a high priority.
The Xpert® MTB/RIF Assay does not provide information on INH-resistance and the LPA is only recommended for use in smear-positive samples, complex to perform and requires manual interpretation. Several novel assays have been recently developed/CE-marked offering high sample throughput and higher sensitivity for detection of MTB, RIF- and INH-resistance in centralized laboratories. However, published data on their performance and operational characteristics is extremely limited.
This is a prospective, multicentre, diagnostic accuracy trial in which the performance of centralised TB assay solutions will be assessed at the intended setting of use with culture, phenotypic DST and sequencing as reference standard.
Potential trial participants will be identified at participating TB clinics or hospitals (enrolment sites). Sputum samples will be collected and transported to the associated TB reference laboratories (testing sites).
In order for the results of this trial to be generalizable, adults with symptoms compatible with pulmonary TB undergoing evaluation will be screened for inclusion at geographically diverse participating centres in high burden TB countries. Additionally, to supplement the drug-resistant cases to timely achieve accurate performance estimates, well-characterized frozen sputum samples from the FIND specimen bank will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB suspects | – | –Sputum specimens will be collected from TB suspects enrolled in the study. The specimens will be tested with 1. Roche cobas MTB - for the detection of Mycobacterium tuberculosis complex 2. Roche cobas MTB-RIF/INH - all specimens that are Mycobacterium tuberculosis complex positive will be reflexed to the Roche cobas MTB-RIF/INH test for the detection of resistance to rifampicin and isoniazid 3. Hain FluoroType MTBDR - for the detection of Mycobacterium tuberculosis complex and the detection of resistance to rifampicin and isoniazid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in whom pulmonary TB is suspected. Additionally, well-characterized RIF-resistant and INH-resistant samples will be used to supplement drug-resistant cases.
Key inclusion criteria (11 listed)
- Patients are eligible to be included as trial participants only if all of the following inclusion criteria apply:
- Aged ≥18 years
- Clinical suspicion of pulmonary TB including cough ≥2 weeks (or any duration if HIV positive ) and ≥1 other symptom typical of pulmonary TB listed below:
Key exclusion criteria (5 listed)
- Participants are excluded from the trial if any of the following exclusion criteria apply:
- Unwilling or unable to provide informed consent
- Unwilling to provide four sputum specimens at enrolment i.e. 2x sputa on day 1 and 2x sputa on day 2 (up to 1 week from enrolment)
- Patients with only extra-pulmonary TB signs \& symptoms
- Receipt of any dose of TB treatment within 6 months prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy for MTB detection
Time frame: four to six months
clinical sensitivity and specificity by smear-status measured against mycobacterial culture as the reference standard.
Diagnostic accuracy for RIF/INH detection
Time frame: four to six months
clinical point estimates of sensitivity and specificity measured against a composite reference standard of phenotypic DST and targeted sequencing.
1 secondary outcome
Operational characteristics:
Time frame: four to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Drug-resistant Tuberculosis, run by Foundation for Innovative New Diagnostics, Switzerland at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India, Georgia, Germany, Moldova, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy for MTB detection (time frame: four to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 31 Oct 2026.