CTRI/2019/07/020139
Not yet recruiting
Phase 2
Phase II : Multicentre clinical study to assess the performance of the Xpert MTB/XDR Assay for INH and Second Line Resistance Detection Xpert MTB/XDR Clinical Evaluation
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: J708- Respiratory conditions due to other specified external agents
- Sponsor
- Foundation for Innovative New Diagnostics India
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years and above
- •Symptoms suggesting pulmonary TB
- •Previously received more than 1 month of treatment for prior TB episode
- •Failing TB treatment with positive smear or culture after three months of standard treatment
- •Close contact with drug resistant TB case
- •Newly diagnosed with MDRTB within the last 30 days
- •Previously diagnosed with MDRTB and failed TB treatment with positive sputum or culture after three months of standard MDRTB treatment
Exclusion Criteria
- •Participants will be excluded from the study if informed consent is not provided
Outcomes
Primary Outcomes
Not specified
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