Status:
COMPLETED
A Prospective Patient Registry of Patients Exposed to Bedaquiline
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Pulmonary Multi-drug Resistant Tuberculosis
Eligibility:
All Genders
Brief Summary
The purpose of this study is to describe the medical indication and utilization of expert medical consultation among participants treated with bedaquiline (BDQ), BDQ susceptibility based on minimum in...
Detailed Description
This is a prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the stud...
Eligibility Criteria
Inclusion
- Participants capable of providing informed consent, which must be obtained prior to collection of any patient outcomes and documented laboratory and clinical variables to meet the study objectives
- Participants who have documented enrollment in the bedaquiline patient registry (BPR) prior to the start of BDQ treatments and documented initiation of BDQ treatment after enrollment
- Participants who have documented initiation of BDQ treatment prior to enrollment and have no documented patient outcomes and documented laboratory and clinical variables to meet the objectives of the study
Exclusion
- No specific exclusion criteria will be applied in this study other than those scenarios that follow from the inclusion criteria
Key Trial Info
Start Date :
December 24 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 20 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02274389
Start Date
December 24 2013
End Date
November 20 2018
Last Update
June 26 2019
Active Locations (1)
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1
Raleigh, North Carolina, United States