Trial · NCT01498419
Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
NCT01498419, Phase 2, Completed, Global Alliance for TB Drug Development; results first posted 2016-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002). Trials, record NCT01498419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01498419
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
- NCT number
- NCT01498419
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 207 participants, actual
- Lead sponsor
- Global Alliance for TB Drug Development
- Conditions
- Pulmonary Tuberculosis
- Interventions
- Moxifloxacin (M), Pretomid (Pa), Pyrazinamide (Z), Rifafour
- First posted
- 2011-12-23
- Last updated
- 2018-06-28
- Results first posted
- 2016-12-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. | 8 weeks | The primary efficacy endpoint was bactericidal activity characterized by the daily rate of change in mean log10CFU counts during 8 weeks of treatment (bactericidal activity assessed by CFU on solid media for days 0-56). |
| Secondary | Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media | 8 weeks | liquid culture = Mycobacteria growth indicator tube (MGIT) Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB |
| Secondary | Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media | Day 57 after eight weeks of daily treatment | Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. (Day 57) |
| Secondary | The Rate of Change in Time to Sputum Culture Positivity (TTP) Through 8 Weeks in the MGIT System in Sputum Over 8 Weeks in Participants as Derived From a Non-linear Regression Model. | 8 weeks | Measurement of TTP in liquid culture media Mycobacteria growth indicator tube (MGIT) using standard procedures |
| Secondary | Percentage of Participants Who Discontinue Due to an Adverse Event in Each Experimental Arm. | 8 weeks | |
| Secondary | Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Solid Media | 8 weeks | Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB |
| Secondary | Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Liquid Media | Day 57 after eight weeks of daily treatment | Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. This was measured at visit 24(Day 57). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. | 8 weeks | The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 173. | log10CFU/ml/day | MEAN |
| SECONDARY | Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media | 8 weeks | The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants included for this outcome was 206. | days | MEDIAN |
| SECONDARY | Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media | Day 57 after eight weeks of daily treatment | The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57. | percentage of participants | NUMBER |
| SECONDARY | The Rate of Change in Time to Sputum Culture Positivity (TTP) Through 8 Weeks in the MGIT System in Sputum Over 8 Weeks in Participants as Derived From a Non-linear Regression Model. | 8 weeks | The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 179. | log10hours/day | MEAN |
| SECONDARY | Percentage of Participants Who Discontinue Due to an Adverse Event in Each Experimental Arm. | 8 weeks | The Safety population was analyzed for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Solid Media | 8 weeks | The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 206. | days | MEDIAN |
| SECONDARY | Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Liquid Media | Day 57 after eight weeks of daily treatment | The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57. | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 0.133 | 95% Confidence Interval 0.109 to 0.155 | log10CFU/ml/day | |
| The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 0.155 | 95% Confidence Interval 0.133 to 0.178 | log10CFU/ml/day | |
| The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. | Drug Sensitive: Rifafour | 0.112 | 95% Confidence Interval 0.093 to 0.131 | log10CFU/ml/day | |
| The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment. | Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) | 0.117 | 95% Confidence Interval 0.070 to 0.174 | log10CFU/ml/day | |
| Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 42.0 | Inter-Quartile Range 35.0 to NA | days | |
| Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 49.0 | Inter-Quartile Range 41.0 to 56.0 | days | |
| Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media | Drug Sensitive: Rifafour | 56.0 | Inter-Quartile Range 43.0 to NA | days | |
| Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media | Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) | 56.0 | Inter-Quartile Range 45.0 to NA | days | |
| Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 82.9 | percentage of participants | ||
| Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 94.3 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 60 | |
| Overall Study | STARTED | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 62 | |
| Overall Study | STARTED | Drug Sensitive: Rifafour | 59 | |
| Overall Study | STARTED | Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) | 26 | |
| Overall Study | COMPLETED | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 42 | |
| Overall Study | COMPLETED | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 39 | |
| Overall Study | COMPLETED | Drug Sensitive: Rifafour | 41 | |
| Overall Study | COMPLETED | Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) | 7 | |
| Overall Study | NOT COMPLETED | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 18 | |
| Overall Study | NOT COMPLETED | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | HYPERURICAEMIA | Metabolism and nutrition disorders | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 17 | 60 | |
| other | HYPERURICAEMIA | Metabolism and nutrition disorders | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 17 | 62 | |
| other | HYPERURICAEMIA | Metabolism and nutrition disorders | Drug Sensitive: Rifafour | 17 | 59 | |
| other | HYPERURICAEMIA | Metabolism and nutrition disorders | Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) | 8 | 26 | |
| other | HYPONATRAEMIA | Metabolism and nutrition disorders | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 8 | 60 | |
| other | HYPONATRAEMIA | Metabolism and nutrition disorders | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 5 | 62 | |
| other | HYPONATRAEMIA | Metabolism and nutrition disorders | Drug Sensitive: Rifafour | 8 | 59 | |
| other | HYPONATRAEMIA | Metabolism and nutrition disorders | Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) | 0 | 26 | |
| other | HYPERGLYCAEMIA | Metabolism and nutrition disorders | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 4 | 60 | |
| other | HYPERGLYCAEMIA | Metabolism and nutrition disorders | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 2 | 62 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | ||
| Total, all-cause mortality | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | ||
| Total, all-cause mortality | Drug Sensitive: Rifafour | ||
| Total, all-cause mortality | Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) | ||
| Total, other adverse events | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 52 | 60 |
| Total, other adverse events | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 57 | 62 |
| Total, other adverse events | Drug Sensitive: Rifafour | 50 | 59 |
| Total, other adverse events | Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg) | 23 | 26 |
| Total, serious adverse events | Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg) | 1 | 60 |
| Total, serious adverse events | Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg) | 7 | 62 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25795076 | 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 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.
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