ISRCTN49676555
Completed
Phase 3
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)
Sequella Inc (USA)0 sites512 target enrollmentNovember 11, 2005
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Active pulmonary tuberculosis.
- Sponsor
- Sequella Inc (USA)
- Enrollment
- 512
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2018 results in https://pubmed.ncbi.nlm.nih.gov/29862945/ (added 12/01/2021)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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