Pulmonary Multi-drug Resistant TuberculosisNCT02274389
A Prospective Patient Registry of Patients Exposed to Bedaquiline
An observational study of Pulmonary Multi-drug Resistant Tuberculosis, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Multi-drug Resistant Tuberculosis
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2013to 20 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will be drawn from the population of all partIcipants treated with bedaquiline (BDQ) in the United States. All participants meeting registry inclusion criteria will be eligible for inclusion in the BDQ patient registry provided they submit the necessary informed consent for participation.
Who may be able to join
- 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
Who cannot join
- No specific exclusion criteria will be applied in this study other than those scenarios that follow from the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- No Intervention
- Keywords
- Pulmonary Multi-drug Resistant Tuberculosis, Bedaquiline, Sirturo, Observational, Prospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionDrug
This is an observational study and participants did not receive any intervention in this study. Participants initiating bedaquiline (BDQ) treatment as decided by healthcare provider, will be prospectively observed.
| Study group | Role | What they receive |
|---|---|---|
| Bedaquiline Patient Registry (BPR) | Not described Receives: Drug: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 24 months after last BDQ dose
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.
Measured: Baseline up to 24 months after last BDQ dose
Maximum Dose of BDQ
Maximum dose of BDQ used will be reported.
Measured: Baseline up to Month 12
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.
Measured: Baseline up to Month 12
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.
Measured: Baseline up to Month 12
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.
Measured: Baseline up to 24 months after last BDQ dose
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.
Measured: Baseline up to 24 months after last BDQ dose
Secondary outcomes (1)
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.
Measured: Baseline up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start24 Dec 2013
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Multi-drug Resistant TuberculosisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274389
- Sponsor's protocol ID
- CR104620
- Other IDs
- RRA-12028, TMC207TBC4001
- Status last verified
- Jun 2019
- First submitted
- 22 Oct 2014
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedaquiline Patient Registry: Prospective Patient Registry of Patients Exposed to Bedaquiline In the United States
- ClinicalTrials.gov ID
- NCT02274389
- Acronym / sponsor ID
- CR104620
- Keywords
- Pulmonary Multi-drug Resistant Tuberculosis, Bedaquiline, Sirturo, Observational, Prospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2013 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bedaquiline Patient Registry (BPR) | – | Drug: No Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will be drawn from the population of all partIcipants treated with bedaquiline (BDQ) in the United States. All participants meeting registry inclusion criteria will be eligible for inclusion in the BDQ patient registry provided they submit the necessary informed consent for participation.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- No specific exclusion criteria will be applied in this study other than those scenarios that follow from the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is an observational study and participants did not receive any intervention in this study. Participants initiating bedaquiline (BDQ) treatment as decided by healthcare provider, will be prospectively observed. | Drug | Bedaquiline Patient Registry (BPR) |
Primary outcome
Percentage of Participants with Medical Indication for Bedaquiline (BDQ) Treatment and Frequency of use of Expert Medical Consultation With BDQ
Time frame: Baseline up to 24 months after last BDQ dose
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.
Number of Participants With BDQ Susceptibility Based on Minimum Inhibitory Concentration (MIC)
Time frame: Baseline up to 24 months after last BDQ dose
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.
Maximum Dose of BDQ
Time frame: Baseline up to Month 12
Maximum dose of BDQ used will be reported.
Total Duration of BDQ Treatment
Time frame: Baseline up to Month 12
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.
Percentage of Participants with Different Drug Distribution Mechanisms Utilized for Drug Administration
Time frame: Baseline up to Month 12
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.
Number of Participants With Clinical and Microbiologic Patient Reported Outcomes
Time frame: Baseline up to 24 months after last BDQ dose
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.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 24 months after last BDQ dose
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.
1 secondary outcome
Comparison of Rate of Observed Outcomes With Nationally Available Reported Rates
Time frame: Baseline up to Month 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
Related trials for Pulmonary Multi-drug Resistant Tuberculosis
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
RecruitingPhase 3
A PAN-USR TB Multi-Center Trial
Pulmonary Tuberculosis
Not yet recruitingObservational study
A Study on the Short - Course Treatment Regimen Containing Pretomanid for Diabetes Mellitus Complicated With Rifampicin - Resistant/Multidrug - Resistant Pulmonary Tuberculosis
Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis, Type 2 Diabetes Mellitus (T2DM)
RecruitingPhase 3
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
Rifampin-Resistant Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant (MDR-TB)
RecruitingPhase 3
Novel Triple-dose Tuberculosis Retreatment Regimen
Multidrug-resistant Tuberculosis, Pulmonary Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Multi-drug Resistant Tuberculosis, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Medical Indication for Bedaquiline (BDQ) Treatment and Frequency of use of Expert Medical Consultation With BDQ (time frame: Baseline up to 24 months after last BDQ dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.