A randomised, placebo-control phase III study to assess the safety and efficacy of the MPT64 patch test in the diagnosis of active tuberculosis (TB)
Phase 3
Completed
- Conditions
- Active pulmonary tuberculosis.Infections and InfestationsTuberculosis
- Registration Number
- ISRCTN49676555
- Lead Sponsor
- Sequella Inc (USA)
- Brief Summary
2018 results in https://pubmed.ncbi.nlm.nih.gov/29862945/ (added 12/01/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 512
Inclusion Criteria
TB suspects undergoing investigation at selected health centres for pulmonary TB within the National TB Control Programme of Peru.
Exclusion Criteria
1. Age less than 18 or greater than 65
2. Inability or unwillingness to provide written informed consent
3. Participation in a clinical trial of another investigational product within the preceding 6 months
4. Refusal to undergo voluntary counselling and testing for human immunodeficiency virus (HIV) infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method