Multidrug-Resistant TuberculosisYDNCT02984579
Line Probe Assay Evaluation Study
An observational study of Multidrug-Resistant Tuberculosis and Isoniazid Resistant Pulmonary Tuberculosis, run by Foundation for Innovative New Diagnostics, Switzerland.
Trial summary
This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB) and at risk of drug resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis, Rifampicin Resistant Tuberculosis
- What is being tested?
- YD REBA MTB-MDR, Hain Genotype MTBDRplus V1 and Hain Genotype MTBDRplus V2
- Type of treatment
- Medical device
- How many people
- 888 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jan 2016
- 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: The study consisted of two phases. In phase 1, each site was sent a different set of 200 clinical isolates from the Research and Training in Tropical Diseases and Institute for Tropical Medicine collections (ITM). In phase 2, samples from 274 patients recruited between Azerbaijan and Moldova were tested in Germany, while samples from 214 (locally-recruited) patients were tested in South Africa.
Who may be able to join
- Age over 18 years
- Informed consent
- Patients evaluated for pulmonary TB
Who cannot join
- -
About this study
Official title: Multi-center Study to Assess the Non-inferiority of YD REBA MTB-MDR® and Hain GenoType® MTBDRplus V2 Line Probe Assays Compared to Hain GenoType® MTBDRplus V1
This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB) and at risk of drug resistance. All testing was done on stored, de-identified leftover samples.
The study involved three World Health Organization (WHO) Supranational Reference Laboratories with well-characterized strain collections and access to sputum samples with significant rates of drug resistance.
- Conditions
- Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis, Rifampicin Resistant Tuberculosis, Pulmonary Tuberculoses
- Being tested
- YD REBA MTB-MDR, Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2
- Medical subject headings
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YD REBA MTB-MDRDevice
Conducted on stored, de-identified leftover samples. A line probe assay designed for detection of Multidrug-resistant tuberculosis (MDR-TB). The REBA MTB-MDR® assay is a qualitative in vitro test for the identification of Mycobacterium tuberculosis (MTB) complex and its susceptibility to rifampin and isoniazid from cultured samples and smear positive specimens.
Hain Genotype MTBDRplus V1Device
Conducted on stored, de-identified leftover samples. There is only one Line Probe Assay for molecular MTB drug resistance globally available, the GenoType® MTBDRplus V.1 from Hain Lifescience. This assay includes rpoB gene probes for Rifampin (RIF) resistance, katG gene probes for high level Isoniazid (INH) resistance, and inhA gene probes for determination of low level INH resistance
Hain Genotype MTBDRplus V2Device
Conducted on stored, de-identified leftover samples. An updated version of the Hain Genotype MTBDRplus V1 assay, the Genotype MTBDRplus V.2 line probe assay, showed increased sensitivity for MTB detection in the 2 studies published so far
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests.
Investigators and Operators were blinded to all other results for a sample upon data entry. Receives: Device: YD REBA MTB-MDR; Device: Hain Genotype MTBDRplus V1; Device: Hain Genotype MTBDRplus V2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
INH/RIF Resistance Detection
Measured: At the end of study 9-10 Months after the Study started
Secondary outcomes (1)
Multi-Drug Resistant TB detection
Is the subject resistant to both INH and RIF
Measured: At the end of study 9-10 Months after the Study started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug-Resistant 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center Borstel, National Institute for Communicable Diseases, South Africa, Institute of Tropical Medicine, Belgium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984579
- Sponsor's protocol ID
- YD7012-03
- Acronym
- YD
- Status last verified
- Feb 2017
- First submitted
- 30 Nov 2016
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study to Assess the Non-inferiority of YD REBA MTB-MDR® and Hain GenoType® MTBDRplus V2 Line Probe Assays Compared to Hain GenoType® MTBDRplus V1
- ClinicalTrials.gov ID
- NCT02984579
- Acronym / sponsor ID
- YD / YD7012-03
- Conditions
- Multidrug-Resistant Tuberculosis, Isoniazid Resistant Pulmonary Tuberculosis, Rifampicin Resistant Tuberculosis, Pulmonary Tuberculoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Research Center Borstel, National Institute for Communicable Diseases, South Africa, Institute of Tropical Medicine, Belgium
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- 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.
This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB) and at risk of drug resistance. All testing was done on stored, de-identified leftover samples.
The study involved three World Health Organization (WHO) Supranational Reference Laboratories with well-characterized strain collections and access to sputum samples with significant rates of drug resistance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | – | Device: YD REBA MTB-MDR, Device: Hain Genotype MTBDRplus V1, Device: Hain Genotype MTBDRplus V2All strains in Phase 1 and all Sputum samples in Phase 2 were tested with Hain Genotype MTBDRplus V1, Hain Genotype MTBDRplus V2, and YD REBA MTB-MDR diagnostic tests. Investigators and Operators were blinded to all other results for a sample upon data entry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study consisted of two phases. In phase 1, each site was sent a different set of 200 clinical isolates from the Research and Training in Tropical Diseases and Institute for Tropical Medicine collections (ITM). In phase 2, samples from 274 patients recruited between Azerbaijan and Moldova were tested in Germany, while samples from 214 (locally-recruited) patients were tested in South Africa.
Key inclusion criteria (3 listed)
- Age over 18 years
- Informed consent
- Patients evaluated for pulmonary TB
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YD REBA MTB-MDRConducted on stored, de-identified leftover samples. A line probe assay designed for detection of Multidrug-resistant tuberculosis (MDR-TB). The REBA MTB-MDR® assay is a qualitative in vitro test for the identification of Mycobacterium tuberculosis (MTB) complex and its susceptibility to rifampin and isoniazid from cultured samples and smear positive specimens. | Device | All Subjects |
| Hain Genotype MTBDRplus V1Conducted on stored, de-identified leftover samples. There is only one Line Probe Assay for molecular MTB drug resistance globally available, the GenoType® MTBDRplus V.1 from Hain Lifescience. This assay includes rpoB gene probes for Rifampin (RIF) resistance, katG gene probes for high level Isoniazid (INH) resistance, and inhA gene probes for determination of low level INH resistance | Device | All Subjects |
| Hain Genotype MTBDRplus V2Conducted on stored, de-identified leftover samples. An updated version of the Hain Genotype MTBDRplus V1 assay, the Genotype MTBDRplus V.2 line probe assay, showed increased sensitivity for MTB detection in the 2 studies published so far | Device | All Subjects |
Primary outcome
INH/RIF Resistance Detection
Time frame: At the end of study 9-10 Months after the Study started
1 secondary outcome
Multi-Drug Resistant TB detection
Time frame: At the end of study 9-10 Months after the Study started
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 3 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidrug-Resistant Tuberculosis and Isoniazid Resistant Pulmonary Tuberculosis, run by Foundation for Innovative New Diagnostics, Switzerland.
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 3 inclusion and 1 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
INH/RIF Resistance Detection (time frame: At the end of study 9-10 Months after the Study started). 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 3 Sep 2026.