Pulmonary Multi-drug Resistant Tuberculosis Clinical Trial
Official title:
Bedaquiline Patient Registry: Prospective Patient Registry of Patients Exposed to Bedaquiline In the United States
Verified date | June 2019 |
Source | Janssen Research & Development, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | November 20, 2018 |
Est. primary completion date | November 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Research & Development, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants with Medical Indication for Bedaquiline (BDQ) Treatment and Frequency of use of Expert Medical Consultation With BDQ | 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. | Baseline up to 24 months after last BDQ dose | |
Primary | Number of Participants With BDQ Susceptibility Based on Minimum Inhibitory Concentration (MIC) | The MIC is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. Number of participants whose post-enrollment isolates exhibit at least 4-fold increase in BDQ MIC in comparison to baseline MIC, provided that the post-baseline MIC is greater than 0.25 milligram per milliliter (mg/mL) based on phenotypic methods on solid or liquid media. | Baseline up to 24 months after last BDQ dose | |
Primary | Maximum Dose of BDQ | Maximum dose of BDQ used will be reported. | Baseline up to Month 12 | |
Primary | Total Duration of BDQ Treatment | Exposure to BDQ will be determined by documentation by the healthcare provider. Duration of BDQ treatment will be calculated from the initiation and discontinuation dates for BDQ. The initiation date for BDQ drug for each participant will be the drug initiation date as reported by the healthcare provider. The discontinuation date will be defined as the date the drug was stopped as reported by the healthcare provider. | Baseline up to Month 12 | |
Primary | Percentage of Participants with Different Drug Distribution Mechanisms Utilized for Drug Administration | Directly observed therapy short-course (DOTS) combines 5 elements: political commitment; microscopy services; drug supplies; surveillance and monitoring systems; and use of highly efficacious regimens with direct observation of treatment. Percentage of participants with drug distribution mechanisms used and DOT use for drug administration will be reported. | Baseline up to Month 12 | |
Primary | Number of Participants With Clinical and Microbiologic Patient Reported Outcomes | The following treatment outcomes will be estimated separately for participants with MDR-TB and participants with non MDR cases or MDR status not documented as per World Health Organization (WHO) Treatment of tuberculosis guidelines: cured, treatment completed, treatment failed, died, lost to follow-up, not evaluated, and treatment success. | Baseline up to 24 months after last BDQ dose | |
Primary | Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product and does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that meets any of the following conditions: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. | Baseline up to 24 months after last BDQ dose | |
Secondary | Comparison of Rate of Observed Outcomes With Nationally Available Reported Rates | Treatment outcome will be evaluated on basis of following parameters; Treatment Completed:without evidence of failure BUT no record that three or more consecutive cultures taken at least 30 days apart are negative after intensive phase; Treatment Failed:Treatment terminated or need for permanent regimen change of at least two anti-tuberculosis drugs because of: Lack of conversion by the end of the intensive phase, or Bacteriological reversion in the continuation phase after conversion to negative, or Evidence of additional acquired resistance to fluoroquinolones or second-line injectable drugs, or Adverse drug reactions; Died:participant who dies for any reason during course of treatment; Lost to Follow-Up:whose treatment was interrupted for 2 consecutive months or more; Not Evaluated:whom no treatment outcome is assigned (this includes cases "transferred out" to another treatment unit and whose treatment outcome is unknown); Treatment Success:The sum of cured and treatment completed. | Baseline up to Month 36 |