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NCT02274389 · ClinicalTrials.gov registry record
A Prospective Patient Registry of Patients Exposed to Bedaquiline
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 5
- Enrollment target
NCT02274389: Completed study, sponsored by Janssen Research & Development.
NCT02274389 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02274389 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Indication for a drug refers to the use of that drug for treating a particular disease. Percentage of participants treated using expert medical consultation will be summarized. Percentage of participants with medical indication for BDQ treatment as reported by the healthcare provider and frequency of use of expert medical consultation in multi-drug resistant tuberculosis (MDR-TB) treatment with BDQ will be reported.
Interventions
- DRUG No Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-12-24 |
| Est. Completion | 2018-11-20 |
What the finished NCT02274389 record still lists
NCT02274389 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No Intervention is the first listed.
NCT02274389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02274389 about?
NCT02274389 is a clinical study titled "A Prospective Patient Registry of Patients Exposed to Bedaquiline". 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 d...
What is the current status of trial NCT02274389?
This trial is currently completed. The enrollment target is 5 participants. The study started on 2013-12-24. Estimated completion is 2018-11-20.
What interventions are being tested in trial NCT02274389?
The interventions under investigation include: No Intervention (DRUG).
Who is sponsoring clinical trial NCT02274389?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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