A Prospective Patient Registry of Patients Exposed to Bedaquiline

Completed

Conditions studied: Pulmonary Multi-drug Resistant Tuberculosis

In brief

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.

Key facts

Study ID: NCT02274389
Run by: Janssen Research & Development, LLC
People needed: 5
Starts: 2013-12-24
Expected to finish: 2018-11-20
Last updated by the study team: 2019-06-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

No specific exclusion criteria will be applied in this study other than those scenarios that follow from the inclusion criteria

Where it is running

Study site — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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