A Prospective Patient Registry of Patients Exposed to Bedaquiline
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/1/2019 |
| Start Date: | December 24, 2013 |
| End Date: | May 31, 2019 |
Bedaquiline Patient Registry: Prospective Patient Registry of Patients Exposed to Bedaquiline In the United States
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.
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.
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 study group) observational (clinical study in which participants may receive
diagnostic, therapeutic, or other types of interventions, but the investigator does not
assign participants to specific interventions) study of participants treated with BDQ.
Participants will be enrolled by their healthcare provider once the healthcare provider
decides to treat with BDQ or after BDQ treatment initiation but prior to observation of any
participant outcomes. All participants meeting the inclusion criteria and providing informed
consent for participation in the study will be enrolled in this study. The registry
enrollment period will be open for 36 months with an additional 24 months BDQ treatment-free
follow-up for safety assessment for the last participants enrolled during the 36 months
enrollment period. Participants' follow-up data will be collected at each visit from the
healthcare provider during the course of BDQ and for an additional 24 months after the last
BDQ dose or until the participant is lost to follow-up. Participants' safety will be
monitored throughout the study.
sufficient number of years to generate incidence or mortality rates subsequent to the
selection of the study group) observational (clinical study in which participants may receive
diagnostic, therapeutic, or other types of interventions, but the investigator does not
assign participants to specific interventions) study of participants treated with BDQ.
Participants will be enrolled by their healthcare provider once the healthcare provider
decides to treat with BDQ or after BDQ treatment initiation but prior to observation of any
participant outcomes. All participants meeting the inclusion criteria and providing informed
consent for participation in the study will be enrolled in this study. The registry
enrollment period will be open for 36 months with an additional 24 months BDQ treatment-free
follow-up for safety assessment for the last participants enrolled during the 36 months
enrollment period. Participants' follow-up data will be collected at each visit from the
healthcare provider during the course of BDQ and for an additional 24 months after the last
BDQ dose or until the participant is lost to follow-up. Participants' safety will be
monitored throughout the study.
Inclusion Criteria:
- 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 Criteria:
- No specific exclusion criteria will be applied in this study other than those
scenarios that follow from the inclusion criteria
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