Trial · NCT02342886
Shortening Treatment by Advancing Novel Drugs
NCT02342886, Phase 3, Completed, Global Alliance for TB Drug Development; results first posted 2019-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Shortening Treatment by Advancing Novel Drugs. Trials, record NCT02342886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02342886
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Shortening Treatment by Advancing Novel Drugs
- NCT number
- NCT02342886
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 284 participants, actual
- Lead sponsor
- Global Alliance for TB Drug Development
- Conditions
- Tuberculosis, Pulmonary, Drug Sensitive, Tuberculosis, Pulmonary, Multi Drug-resistant
- Interventions
- Moxifloxacin, PA-824, Pyrazinamide, HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination), HR (rifampicin plus isoniazid combination tablets)
- First posted
- 2015-01-21
- Last updated
- 2019-03-26
- Results first posted
- 2019-03-26
- Limitations and caveats
Following 3 deaths associated with hepatotoxicity, recruitment was suspended, followed by a partial clinical hold by the United States Food and Drug Association. The hold was removed but the Sponsor permanently stopped recruitment in December 2016.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | From Day 1 to Month 12. | Patients were classified as having a favorable, unfavorable or unassessable status at 12 months from the start of therapy. A favourable status was a negative culture status at 12 months from start of therapy in patients who had not already been classified as having an unfavorable outcome, and whose last positive culture result was followed by at least 2 negative culture results. Patients with an unfavorable status did not achieve/maintain culture negative status, or previously had culture negative status who following end of treatment (EOT), had 2 positive cultures, or had a positive culture not followed by 2 negative cultures, or were dying from any cause during treatment (except accidental cause not including suicide), or were dying from TB related causes during follow-up, or required an extension, restart or change of treatment except for reinfection/pregnancy, or failed to complete adequate treatment who were unassessable at 12 months or lost to follow-up/withdrawn before EOT. |
| Primary | Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Per Protocol [PP] Population) | From Day 1 to Month 12. | Patients were classified as having a favorable, unfavorable or unassessable status at 12 months from the start of therapy. A favourable status was a negative culture status at 12 months from start of therapy in patients who had not already been classified as having an unfavorable outcome, and whose last positive culture result was followed by at least 2 negative culture results. Patients with an unfavorable status did not achieve/maintain culture negative status, or previously had culture negative status who following EOT, had 2 positive cultures, or had a positive culture not followed by 2 negative cultures, or died from any cause during treatment (except accidental cause not including suicide), or were dying from TB related causes during follow-up, or required a restart or change of treatment because of an unfavorable outcome with or without bacteriological confirmation, ie, on bacteriological, radiographic or clinical grounds. |
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 | Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | From Day 1 to Month 12. | The MITT population included all randomized patients excluding late screening failures, lost to follow-up/withdrawn patients who were culture negative, pregnancy, accidental death during treatment, death during follow-up without TB relapse evidence, re-infection with new TB strain + missing/contaminated Month 12 sputum sample. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Per Protocol [PP] Population) | From Day 1 to Month 12. | The PP population consisted of the MITT population, excluding patients who were lost to follow-up/withdrawn, had modified/extended treatment for reasons other than unfavourable therapeutic response, did not receive adequate amount of allocated study regimen and patients with major protocol deviations, unless already classified as unfavourable. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | Favorable | 38 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | Favorable | 46 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | Favorable | 43 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | DS-TB: 2 Months HRZE / 4 Months HR | Favorable | 52 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | Favorable | 10 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | Unfavorable | 19 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | Unfavorable | 15 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | Unfavorable | 13 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | DS-TB: 2 Months HRZE / 4 Months HR | Unfavorable | 8 | Participants | |
| Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population) | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | Unfavorable | 1 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | 65 | |
| Overall Study | STARTED | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 71 | |
| Overall Study | STARTED | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 67 | |
| Overall Study | STARTED | DS-TB: 2 Months HRZE / 4 Months HR | 68 | |
| Overall Study | STARTED | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 13 | |
| Overall Study | Completed Month 12 Follow-Up | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | 43 | |
| Overall Study | Completed Month 12 Follow-Up | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 52 | |
| Overall Study | Completed Month 12 Follow-Up | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 49 | |
| Overall Study | Completed Month 12 Follow-Up | DS-TB: 2 Months HRZE / 4 Months HR | 57 | |
| Overall Study | Completed Month 12 Follow-Up | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 10 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events410
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 | Aspartate aminotransferase increased | Investigations | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | 15 | 65 | |
| other | Aspartate aminotransferase increased | Investigations | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 10 | 71 | |
| other | Aspartate aminotransferase increased | Investigations | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 15 | 67 | |
| other | Aspartate aminotransferase increased | Investigations | DS-TB: 2 Months HRZE/ 4 Months HR | 17 | 68 | |
| other | Aspartate aminotransferase increased | Investigations | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 1 | 13 | |
| other | Alanine aminotransferase increased | Investigations | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | 13 | 65 | |
| other | Alanine aminotransferase increased | Investigations | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 10 | 71 | |
| other | Alanine aminotransferase increased | Investigations | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 14 | 67 | |
| other | Alanine aminotransferase increased | Investigations | DS-TB: 2 Months HRZE/ 4 Months HR | 11 | 68 | |
| other | Alanine aminotransferase increased | Investigations | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 1 | 13 |
1 to 10 of 410Source ClinicalTrials.gov
See all 410 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | 4 | 65 |
| Total, all-cause mortality | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 3 | 71 |
| Total, all-cause mortality | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 3 | 67 |
| Total, all-cause mortality | DS-TB: 2 Months HRZE/ 4 Months HR | 2 | 68 |
| Total, all-cause mortality | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 1 | 13 |
| Total, other adverse events | DS-TB: 4 Months Moxifloxacin + PA-824 (100 mg) + Pyrazinamide | 61 | 65 |
| Total, other adverse events | DS-TB: 4 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 62 | 71 |
| Total, other adverse events | DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 63 | 67 |
| Total, other adverse events | DS-TB: 2 Months HRZE/ 4 Months HR | 62 | 68 |
| Total, other adverse events | MDR-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide | 12 | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02342886
GET https://conductscience.org/api/trials/v1/NCT02342886/flow?page=2