Bioneer IRONqPCR ™ RFIA Kit Kit Clinical Evaluation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05117788 |
Recruitment Status :
Active, not recruiting
First Posted : November 11, 2021
Last Update Posted : October 10, 2023
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Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer IRONqPCR ™ RFIA Kit is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making.
The rapid diagnosis and appropriate treatment of M/XDR-TB is essential to prevent significant morbidity, mortality and further transmission of disease. The FQ are key components of the new bedaquiline-containing 6-9 month regimen, and so it is necessary to rule-out resistance to these compounds prior to treating patients with the shorter regimen. Currently there are no WHO endorsed tests that can identify resistance to both first and second-line drugs in one reaction.
Condition or disease |
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Tuberculosis, Multidrug-Resistant |
Study Type : | Observational |
Actual Enrollment : | 1372 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Multicentre Clinical Study to Assess the Performance of the Bioneer Q-RFIA PCR Kit on IRON qPCR for the Detection of MTB and Resistance to Rifampicin, Isoniazid, Fluoroquinolones and Aminoglycosides |
Actual Study Start Date : | February 23, 2022 |
Estimated Primary Completion Date : | May 30, 2024 |
Estimated Study Completion Date : | June 1, 2024 |
Group/Cohort |
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TB suspects
Sputum specimens will be collected from TB suspects enrolled in the study. The specimens will be tested with
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- Diagnostic accuracy for MTB detection [ Time Frame: 8 months ]point estimates of sensitivity and specificity with 95% CI measured by subgroup (smear status, sample type, site, HIV status and TB history)
- diagnostic accuracy for isoniazid (INH), rifampicin (RIF), fluoroquinolone (FQ) and aminoglycoside (AMG) resistance detection [ Time Frame: 8 months ]Point estimates of sensitivity and specificity estimates with 95% CI for INH, RIF, FQ and AMG resistance detection using phenotypic DST and sequencing as composite reference standard
- The diagnostic accuracy for MTB detection by subgroup (smear status, sample type, site, HIV status and TB history). [ Time Frame: 3 months ]point estimates of sensitivity and specificity with 95% CI measured by subgroup (smear status, sample type, site, HIV status and TB history).
- Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA kit for MTB detection to Xpert Ultra [ Time Frame: 8 months ]Estimate the difference in sensitivity and specificity between the Bioneer IRONqPCR ™ RFIA Kit and Xpert Ultra for MTB detection
- Diagnostic accuracy for resistance detection of the Bioneer IRONqPCR ™ RFIA Kit by subgroup (smear status, sample type, site, smear status, by gene target) [ Time Frame: 8 months ]clinical point estimates of sensitivity and specificity measured by subgroup (smear status, sample type, site, HIV status and TB history).
- Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA Kit [ Time Frame: 8 months ]Estimate the difference in sensitivity and specificity between the Bioneer IRONqPCR ™ RFIA Kit and Xpert Ultra for RIF resistance detection
- Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA Kit for resistance detection to the GenoType MTBDRplus and MTBDRsl assays [ Time Frame: 8 months ]Estimate the difference in sensitivity and specificity between the Bioneer IRONqPCR ™ RFIA Kit and the GenoType MTBDRplus and MTBDRsl assays for resistance detection
- Compare the diagnostic accuracy of the Bioneer IRONqPCR ™ RFIA Kit for resistance detection to Xpert MTB/XDR [ Time Frame: 8 months ]Estimate the difference in sensitivity and specificity between the Bioneer IRONqPCR ™ RFIA Kit and Xpert MTB/XDR
- Assess Bioneer IRONqPCR ™ RFIA Kit technical performance, including non-determinant rates, ease of use and other systems operational characteristics. [ Time Frame: 8 months ]Assessment of Bioneer IRONqPCR ™ RFIA Kit technical performance, including percentage of invalid results, percentage of indeterminate results for MTB detection, and percentage of indeterminate results for resistance detection
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- People (aged ≥18 years)
- Clinical signs and symptoms of pulmonary TB including cough ≥2 weeks and ≥1 other symptom typical of pulmonary TB (fever, malaise, recent weight loss, night sweats, hemoptysis).
Exclusion Criteria:
- Absence of informed consent (Unwilling or unable to provide informed consent)
- Insufficient sample volume or number,
- Receipt of any dose of TB treatment within six months prior to enrolment.
- Unwilling to provide two sputum specimens at enrolment
- Patients with only extra-pulmonary TB signs & symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117788
Kenya | |
KEMRI | |
Nairobi, Kenya | |
Peru | |
Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia | |
Lima, Peru | |
Ukraine | |
V.N Karazin Kharkiv National University | |
Kharkiv, Ukraine, 61064 |
Principal Investigator: | Morten Ruwhald, Ph.D. | Foundation for Innovative New Diagnostics |
Responsible Party: | Foundation for Innovative New Diagnostics, Switzerland |
ClinicalTrials.gov Identifier: | NCT05117788 |
Other Study ID Numbers: |
7217-2/1_TB040 |
First Posted: | November 11, 2021 Key Record Dates |
Last Update Posted: | October 10, 2023 |
Last Verified: | October 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tuberculosis Tuberculosis, Multidrug-Resistant Mycobacterium Infections Actinomycetales Infections |
Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |