Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04147676
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2019-10-30
Brief Title:
Evaluation of Centralised TB Assay Solutions
Sponsor:
Foundation for Innovative New Diagnostics Switzerland
Organization:
Foundation for Innovative New Diagnostics Switzerland
Study Overview
Official Title:
Multicentre Trial to Assess the Performance of Centralized Assay Solutions for Detection of MTB and Resistance to Rifampin and Isoniazid
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Development of rapid molecular diagnostic tests for the identification of Mycobacterium tuberculosis MTB and drug resistance has become a high priority
The Xpert MTBRIF 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 developedCE-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
The Xpert MTBRIF 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 developedCE-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None