Trial · NCT02193776
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
NCT02193776, Phase 2, Completed, Global Alliance for TB Drug Development; results first posted 2019-07-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis. Trials, record NCT02193776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02193776
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.
- NCT number
- NCT02193776
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 240 participants, actual
- Lead sponsor
- Global Alliance for TB Drug Development
- Conditions
- Tuberculosis
- Interventions
- PA-824, bedaquiline, moxifloxacin, pyrazinamide, isoniazid, rifampicin, pyrazinamide and ethambutol combination tablet
- First posted
- 2014-07-18
- Last updated
- 2019-07-26
- Results first posted
- 2019-07-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System | Day 0 to Day 56 (8 weeks) | The bactericidal activity (BA) was determined by the rate of change in TTP collected from overnight sputum samples over 8 weeks of treatment in the liquid culture media MGIT system, represented by the model-fitted log(TTP) results as calculated by the regression of the observed log(TTP) results over time. The bactericidal activity of log(TTP) over Day 0 to Day 56 (BATTP\[0-56\]) was presented and expressed as the daily percentage change in TTP from Day 0 to Day 56. The mean BATTP (0-56) was calculated from Bayesian non-linear mixed effects regression models fitted to log(TTP) collected from sputum samples (observed from Day 0 to Day 56). |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | First study drug administration (Day 1) up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having the Day 70 follow-up visit) (70 days) | A TEAE was defined as any AE which started or worsened on or after first study drug administration up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having Day 70 follow-up visit). Drug-related TEAEs were defined as TEAEs for which relationship to study drug was indicated as 'possible', 'probable', 'certain' or missing. TEAEs leading to death were defined as TEAEs resulted 'fatal' outcome. Serious TEAEs were defined as TEAEs for which serious was indicated as 'yes'. TEAEs leading to discontinuation of study drug were defined as TEAEs for which action taken with study drug was indicated as 'study drug stopped'. TEAEs leading to early withdrawal from study were defined as TEAEs resulted study discontinuation. Grade III and IV TEAEs were defined as TEAEs for which severity (DMID grade) was indicated as 'Grade 3 (severe)' and 'Grade 4 (potentially life-threatening)' or missing, respectively. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System | Day 0 to Day 56 (8 weeks) | The modified intention-to-treat analysis population included all participants included in the safety analysis population for whom valid corresponding efficacy data were available. Pyrazinamide resistant participants were excluded from this analysis population (applicable to both participants with DS-TB and MDR-TB). | percentage change in TTP/day | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | First study drug administration (Day 1) up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having the Day 70 follow-up visit) (70 days) | The safety analysis population included all participants who were randomized (for the DS participant population) or assigned (for the MDR participant population) to study drug and received at least 1 administration of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 4.878 | Standard Deviation 1.604 | percentage change in TTP/day | |
| Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 5.182 | Standard Deviation 1.466 | percentage change in TTP/day | |
| Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System | DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) | 4.046 | Standard Deviation 1.129 | percentage change in TTP/day | |
| Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System | MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide | 5.194 | Standard Deviation 1.068 | percentage change in TTP/day | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | Any TEAE | 50 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | Any TEAE | 45 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) | Any TEAE | 44 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide | Any TEAE | 57 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | Drug-related TEAE | 38 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | Drug-related TEAE | 29 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 59 | |
| Overall Study | STARTED | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 60 | |
| Overall Study | STARTED | DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) | 61 | |
| Overall Study | STARTED | MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide | 60 | |
| Overall Study | Completed Day 70 Follow-up | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 54 | |
| Overall Study | Completed Day 70 Follow-up | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 56 | |
| Overall Study | Completed Day 70 Follow-up | DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) | 60 | |
| Overall Study | Completed Day 70 Follow-up | MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide | 60 | |
| Overall Study | Completed Day 140 Follow-up | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 52 | |
| Overall Study | Completed Day 140 Follow-up | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 52 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood uric acid increased | Investigations | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 15 | 59 | |
| other | Blood uric acid increased | Investigations | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 13 | 60 | |
| other | Blood uric acid increased | Investigations | DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) | 9 | 61 | |
| other | Blood uric acid increased | Investigations | MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide | 27 | 60 | |
| other | Alanine aminotransferase increased | Investigations | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 3 | 59 | |
| other | Alanine aminotransferase increased | Investigations | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 5 | 60 | |
| other | Alanine aminotransferase increased | Investigations | DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) | 2 | 61 | |
| other | Alanine aminotransferase increased | Investigations | MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide | 2 | 60 | |
| other | Aspartate aminotransferase increased | Investigations | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 3 | 59 | |
| other | Aspartate aminotransferase increased | Investigations | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 3 | 60 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 2 | 59 |
| Total, all-cause mortality | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 3 | 60 |
| Total, all-cause mortality | DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) | 2 | 61 |
| Total, all-cause mortality | MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide | 4 | 60 |
| Total, other adverse events | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 50 | 59 |
| Total, other adverse events | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 45 | 60 |
| Total, other adverse events | DS-TB: HRZE (Isoniazid+Rifampicin+Pyrazinamide+Ethambutol) | 44 | 61 |
| Total, other adverse events | MDR-TB: Bedaquiline (200 mg)+Moxifloxacin+PA-824+Pyrazinamide | 57 | 60 |
| Total, serious adverse events | DS-TB: Bedaquiline (Loading Dose/t.i.w)+ PA-824 + Pyrazinamide | 4 | 59 |
| Total, serious adverse events | DS-TB: Bedaquiline (200 mg) + PA-824 + Pyrazinamide | 3 | 60 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31732485 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02193776
GET https://conductscience.org/api/trials/v1/NCT02193776/results?page=2