Overview

A Prospective Patient Registry of Patients Exposed to Bedaquiline

Status:
Completed
Trial end date:
2018-11-20
Target enrollment:
Participant gender:
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 inhibitory concentrations (MICs) reported for baseline and subsequent isolates, BDQ drug utilization data to include dose, duration, past treatment history, past medical history, concomitant medications, and health care site of treatment, drug distribution mechanisms used in the administration of BDQ, patient outcomes (clinical and microbiologic) and adverse events among BDQ-treated participants, including deaths.
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Bedaquiline
Diarylquinolines