Xpert MTB/XDR Clinical Evaluation Trial
- Conditions
- Tuberculosis, Multidrug-ResistantTuberculosis, Pulmonary
- Registration Number
- NCT03728725
- Lead Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Brief Summary
FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 710
-
• Age 18 years or above;
-
Symptoms suggesting pulmonary TB, i.e. persistent cough (generally ≥3 weeks or as per local definition of TB suspect), and at least one of the following:
- Previously received >1 month of treatment for a prior TB episode or
- Failing TB treatment with positive sputum smear or culture after ≥3 months of a standard TB treatment or
- Had close contact with a known drug-resistant TB case or
- Newly diagnosed with MDR-TB within the last 30 days or
- Previously diagnosed with MDR-TB and failed TB treatment with positive sputum smear or culture after ≥3 months of a standard MDR-TB treatment regimen
-
Patients meeting the above criteria will be screened by Xpert MTB/RIF or Xpert MTB/RIF Ultra. TB patients meeting the following criteria will be included in the study:
- A clear Mtb-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Xpert MTB/RIF Ultra
- Provision of informed consent;
- Production of an adequate quantity (>3mL) of sputum
- Participants will be excluded from the study if informed consent is not provided.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection Day 1 Sensitivity and specificity estimates for INH and ETH resistance detection
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection Day 1 Sensitivity and specificity estimates for fluoroquinolone resistance detection
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection Day 1 Sensitivity and specificity estimates for second-line injectable resistance detection
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Institute of Pthisiopenumology
🇲🇩Chisinau, Moldova, Republic of
Institute of Pthisiopenumology🇲🇩Chisinau, Moldova, Republic of