Multicentre trial to assess theperformance of centralized assaysolutions for detection of MTB and resistance to Rifampin and Isoniazid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- 1.Diagnostic accuracy for MTB detection: clinical sensitivity
Study Overview
Brief Summary
Cross-sectional diagnostic accuracy study with culture, phenotypic DST and sequencing as reference standards and Xpert MTB/RIF (or Ultra) as a comparator. Results from the FluoroType MTBDR V2 assay will not be used to make clinical decisions. Participants in whom pulmonary TB is suspected. Additionally,
well-characterized RIF-resistant and INH-resistant samples will be used to supplement drug-resistant cases. The primary Objective is to Estimate diagnostic accuracy of FluoroType MTBDR V2 assay for MTB detection for smear-positive and smear negative TB, including Xpert MTB/RIF (or Ultra) as a comparator and culture as the reference standard and to Estimate diagnostic accuracy of FluoroType MTBDR V2 assay for resistance detection (RIF/INH) with sequencing and phenotypic DST as the reference standard.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Aged Equal ore more than 18 years.
- •Clinical suspicion of pulmonary TB including productive cough of equal or more than 2 weeks and equal or more than 1 week for other symptom typical of pulmonary TB listed below: 2.
- •Contact with active case 2.
- •Haemoptysis 2.
- •Recent weight Loss 2.
- •Chest Pain 2.
- •Night sweats 2.
- •Loss of appetite 3) Willing to Provide two sputum specimens at enrollment 4) Willing to provide informed consent.
Exclusion Criteria
- •Only extra-pulmonary TB signs & symptoms 2) Receipt of any dose of TB treatment within 6 months prior to enrolment or currently on TB treatment.
Outcomes
Primary Outcomes
1.Diagnostic accuracy for MTB detection: clinical sensitivity
Time Frame: Baseline
and specificity by smear-status measured against
Time Frame: Baseline
mycobacterial culture as the reference standard.
Time Frame: Baseline
Secondary Outcomes
- 1) Diagnostic accuracy for MTB detection:clinical point estimates of sensitivity and specificity measured against(mycobacterial culture as the reference standard by sub gr oup.)