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Clinical Trial Summary

Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR 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.


Clinical Trial Description

Title Phase II: Multicentre Clinical Study to Assess the Performance of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for INH-, RIF-, FQ- and AG-Resistance Detection Background and rationale Evidence of the clinical diagnostic accuracy and operational characteristics of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR is needed to comprehensively evaluate Bioneer RFIA validity and inform global and national policy decision-making. Primary objectives 1.1 Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for MTB detection 1.2 Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for isoniazid resistance detection 1.3 Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for rifampicin resistance detection 1.4 Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for fluoroquinolone resistance detection 1.5 Estimate the diagnostic accuracy of the Bioneer Accupower Q-RFIA PCR kit on IRON qPCR for aminoglycoside-resistance detection 1.6 Assess Bioneer Accupower Q-RFIA PCR kit on IRON qPCR technical performance, including non-determinant rates, ease of use and other systems operational characteristics. Secondary objectives 2.1 Assess additional Bioneer Accupower Q-RFIA PCR kit on IRON qPCR performance characteristics, including direct performance versus performance on cultured samples, performance between sites, by smear result, by gene target and compared to the GenoType MTBDRplus and MTBDRsl assays Study population People to be evaluated for TB. Additionally, locally available well-characterized rifampicin-, isoniazid-, fluoroquinolone- and second-line injectable-resistant samples will be used to supplement drug-resistant cases. Resistant cases can also be supplemented from the FIND specimen bank. Sample size 1,000 TB suspects across sites. Resistant cases will be supplemented locally or from the FIND specimen bank: 127 rifampicin-resistant, 140 isoniazid-resistant, 93 fluoroquinolone, 34 amikacin-resistant, 71 kanamycin-resistant and 34 capreomycin-resistant specimens Eligibility criteria People (aged ≥18 years) with clinical signs and symptoms of pulmonary TB including cough ≥2 weeks and ≥1 other symptom typical of pulmonary TB Exclusion criteria comprise absence of informed consent, insufficient sample volume or number, only extra-pulmonary TB signs & symptoms, and receipt of any dose of TB treatment within six months prior to enrolment. Primary endpoints 1.1 Sensitivity and specificity estimates for MTB detection 1.2 Sensitivity and specificity estimates for INH resistance detection 1.3 Sensitivity and specificity estimates for RIF resistance detection 1.4 Sensitivity and specificity estimates for FQ resistance detection 1.5 Sensitivity and specificity estimates for AG resistance detection 1.6 Assessment of Bioneer Accupower Q-RFIA PCR kit on IRON qPCR technical performance Secondary endpoints 2.1 Assessment of additional Bioneer Accupower Q-RFIA PCR kit on IRON qPCR performance characteristics GCP statement This study will be conducted in compliance with the protocol, the Declaration of Helsinki, ICH-GCP, ISO 13485: 2016 (if applicable) as well as all national legal and regulatory requirements. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05117788
Study type Observational
Source Foundation for Innovative New Diagnostics, Switzerland
Contact Margaretha de Vos, PhD
Phone +41 (0) 22 710 05 90
Email [email protected]
Status Not yet recruiting
Phase
Start date January 2022
Completion date December 2022

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