Trial · NCT03338621
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
NCT03338621, Phase 2, Phase 3, Completed, Global Alliance for TB Drug Development; results first posted 2023-11-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients. Trials, record NCT03338621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03338621
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
- NCT number
- NCT03338621
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 455 participants, actual
- Lead sponsor
- Global Alliance for TB Drug Development
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Drug-Resistant Tuberculosis
- Interventions
- Pretomanid, Bedaquiline, Moxifloxacin, Pyrazinamide, HRZE, HR
- First posted
- 2017-11-09
- Last updated
- 2026-08-27
- Results first posted
- 2023-11-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Culture Negative Status by 8 Weeks | Days 0-56 (8 weeks) | Culture negative status is achieved when a participant produces at least two negative culture results at different visits (at least 7 days apart) without an intervening positive culture result for M.tb. |
| Secondary | Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | 52 weeks after start of therapy | Unfavorable status: 1. Participants not classified as having achieved or maintained culture negative status when last seen 2. Participants previously classified as having culture negative status who, following the end of treatment, have two positive cultures without an intervening negative culture 3. Participants who had a positive culture not followed by at least two negative cultures when last seen 4. Participants dying from any cause during treatment, except from violent or accidental cause, not including suicide 5. Participants definitely or possibly dying from TB related cause during the follow-up phase 6. Participants requiring an extension of their treatment beyond that permitted by the protocol a restart or a change of treatment for any reason except reinfection or pregnancy 7. Participants lost to follow up or withdrawn from the study before end of treatment |
| Secondary | Time to Culture Negative Status | During treatment (17 or 26 weeks) | Culture conversion is a diagnostic criteria indicating the point at which samples taken from a patient infected with a tuberculosis can no longer produce tuberculosis cell cultures, that point is considered culture negativity |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Culture Negative Status by 8 Weeks | Days 0-56 (8 weeks) | Limited to Drug Sensitive TB groups. Participants were considered unassessable and therefore excluded from the Modified Intent to Treat (MITT) population if they were late exclusion or if they did not have culture confirmation of M.tb at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | 52 weeks after start of therapy | TB Specific Modified Intent to Treat (TB-MITT) population participants were unassessable and excluded if they were a late exclusion, became pregnant and stopped treatment, had suspected or confirmed COVID-19 and stopped treatment, died during treatment from violent or accidental cause, died during follow-up with no evidence of TB, reinfected with a different strain of TB, had contaminated or missing sputum samples at the endpoint visit (and able to produce sputum). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Culture Negative Status | During treatment (17 or 26 weeks) | Participants were unassessable and excluded from the Modified Intent to Treat (MITT) population if they were a late exclusions. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Culture Negative Status by 8 Weeks | Drug Sensitive-TB 2HRZE/4HR | 70 | Participants | ||
| Number of Participants With Culture Negative Status by 8 Weeks | Drug Sensitive-TB 4BPaMZ | 122 | Participants | ||
| Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | Drug Sensitive-TB 4BPaMZ | Favorable | 120 | Participants | |
| Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | Drug Sensitive-TB 2HRZE/4HR | Favorable | 134 | Participants | |
| Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | Drug Resistant-TB 6BPaMZ | Favorable | 111 | Participants | |
| Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | Drug Sensitive-TB 4BPaMZ | Unfavorable | 24 | Participants | |
| Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | Drug Sensitive-TB 2HRZE/4HR | Unfavorable | 10 | Participants | |
| Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) | Drug Resistant-TB 6BPaMZ | Unfavorable | 22 | Participants | |
| Time to Culture Negative Status | Drug Sensitive-TB BPaMZ | 6 | Inter-Quartile Range 4 to 8 | weeks | |
| Time to Culture Negative Status | Drug Sensitive-TB 2HRZE/4HR | 11 | Inter-Quartile Range 6 to 12 | weeks |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Drug Sensitive-TB 4BPaMZ | 150 | |
| Overall Study | STARTED | Drug Sensitive-TB 2HRZE/4HR | 153 | |
| Overall Study | STARTED | Drug Resistant-TB 6BPaMZ | 152 | |
| Overall Study | COMPLETED | Drug Sensitive-TB 4BPaMZ | 121 | |
| Overall Study | COMPLETED | Drug Sensitive-TB 2HRZE/4HR | 134 | |
| Overall Study | COMPLETED | Drug Resistant-TB 6BPaMZ | 117 | |
| Overall Study | NOT COMPLETED | Drug Sensitive-TB 4BPaMZ | 29 | |
| Overall Study | NOT COMPLETED | Drug Sensitive-TB 2HRZE/4HR | 19 | |
| Overall Study | NOT COMPLETED | Drug Resistant-TB 6BPaMZ | 35 |
Source ClinicalTrials.gov
Adverse events165
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 | Anemia | Blood and lymphatic system disorders | Drug Sensitive-TB BPaMZ | 9 | 150 | |
| other | Anemia | Blood and lymphatic system disorders | Drug Sensitive-TB 2HRZE/4HR | 9 | 153 | |
| other | Anemia | Blood and lymphatic system disorders | Drug Resistant-TB BPaMZ | 7 | 149 | |
| other | Diarrhoea | Gastrointestinal disorders | Drug Sensitive-TB BPaMZ | 11 | 150 | |
| other | Diarrhoea | Gastrointestinal disorders | Drug Sensitive-TB 2HRZE/4HR | 5 | 153 | |
| other | Diarrhoea | Gastrointestinal disorders | Drug Resistant-TB BPaMZ | 18 | 149 | |
| other | Gastritis | Gastrointestinal disorders | Drug Sensitive-TB BPaMZ | 12 | 150 | |
| other | Gastritis | Gastrointestinal disorders | Drug Sensitive-TB 2HRZE/4HR | 0 | 153 | |
| other | Gastritis | Gastrointestinal disorders | Drug Resistant-TB BPaMZ | 12 | 149 | |
| other | Nausea | Gastrointestinal disorders | Drug Sensitive-TB BPaMZ | 21 | 150 |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Drug Sensitive-TB BPaMZ | 3 | 150 |
| Total, all-cause mortality | Drug Sensitive-TB 2HRZE/4HR | 2 | 153 |
| Total, all-cause mortality | Drug Resistant-TB BPaMZ | 4 | 149 |
| Total, other adverse events | Drug Sensitive-TB BPaMZ | 139 | 150 |
| Total, other adverse events | Drug Sensitive-TB 2HRZE/4HR | 144 | 153 |
| Total, other adverse events | Drug Resistant-TB BPaMZ | 142 | 149 |
| Total, serious adverse events | Drug Sensitive-TB BPaMZ | 17 | 150 |
| Total, serious adverse events | Drug Sensitive-TB 2HRZE/4HR | 7 | 153 |
| Total, serious adverse events | Drug Resistant-TB BPaMZ | 16 | 149 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38768617 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Drug Sensitive-TB 2HRZE/4HR vs Drug Sensitive-TB 4BPaMZ: Number of Participants With Culture Negative Status by 8 Weeks |
Source Trial comparisons
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/NCT03338621
GET https://conductscience.org/api/trials/v1/NCT03338621/events?page=2