Trial · NCT00864383
Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis
NCT00864383, Phase 3, Completed, Global Alliance for TB Drug Development; results first posted 2015-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis. Trials, record NCT00864383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00864383
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis
- NCT number
- NCT00864383
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,931 participants, actual
- Lead sponsor
- Global Alliance for TB Drug Development
- Conditions
- Pulmonary Tuberculosis
- Interventions
- Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin
- First posted
- 2009-03-18
- Last updated
- 2017-03-21
- Other registries' IDs
- isrctn:ISRCTN85595810
- Results first posted
- 2015-05-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ). | 18 months (within one year of completion of therapy) | The primary efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome). Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. For the final 18 month study visit when both L-J samples were contaminated or missing, if the subject could not be brought back, liquid medium culture results were used in place of solid medium culture results. |
| Primary | Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting) | 18 months (within one year of completion of therapy) | The number of participants includes all patients who had at least one grade 3 or 4 adverse event. |
| Secondary | Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT). | 18 months (within one year of completion of therapy) | The secondary analysis of efficacy outcome was the proportion of patients who had bacteriologically or clinically defined failure or relapse within 18 months after randomization (a composite unfavorable outcome) based on MGIT. Culture-negative status was defined as two negative-culture results at different visits without an intervening positive result. The date of culture-negative status was defined as the date of the first negative-culture result. This status continued until there were two positive cultures, without an intervening negative culture, or until there was a single positive culture that was not followed by two negative cultures. Relapse strains were those shown to be identical on 24-locus Mycobacterial interspersed repetitive units (MIRU) analysis. |
| Secondary | Number of Patients Who Are Culture Negative (Solid LJ Culture) | 8 weeks | Number of patients who are TB LJ culture negative at 8 weeks. |
| Secondary | Number of Patients Who Are Culture Negative (Liquid MGIT Culture) | 8 weeks | Number of patients who are TB MGIT culture negative at 8 weeks. |
| Secondary | Time to First Culture Negative Sputum Sample (LJ Solid Media) | 18 months | Culture negative for TB using LJ cultures. |
| Secondary | Time to First Culture Negative Sputum Sample (MGIT Liquid Media) | 18 months | |
| Secondary | Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media. | 18 months | Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Unfavorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result ("isolated positive culture") was followed by at least two negative culture results. |
| Secondary | Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media. | 18 months | Sensitivity Analysis of Primary Efficacy Results of All Randomized Subjects Imputing Favorable for Missing Outcomes. Analysis is the number of subjects with an unfavorable outcome. Favorable outcome is defined as the number of subjects with a negative TB culture status at 18 months (at or after 72 weeks), who had not already been classified as having an unfavorable outcome, and whose last positive TB culture result ("isolated positive culture") was followed by at least two negative culture results. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ). | 18 months (within one year of completion of therapy) | Per protocol population | participants with failure or relapse | NUMBER |
| PRIMARY | Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting) | 18 months (within one year of completion of therapy) | Safety population, defined as all subjects who underwent randomization and who received at least on dose of study drug. | participants with Grade 3 or 4 AEs | NUMBER |
| SECONDARY | Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT). | 18 months (within one year of completion of therapy) | Per protocol population | participants with failure or relapse | NUMBER |
| SECONDARY | Number of Patients Who Are Culture Negative (Solid LJ Culture) | 8 weeks | Per protocol | participants who are culture negative | NUMBER |
| SECONDARY | Number of Patients Who Are Culture Negative (Liquid MGIT Culture) | 8 weeks | participants who are culture negative | NUMBER | |
| SECONDARY | Time to First Culture Negative Sputum Sample (LJ Solid Media) | 18 months | All randomized patients excluding late screen failures | Time to culture negative status / weeks | MEDIAN |
| SECONDARY | Time to First Culture Negative Sputum Sample (MGIT Liquid Media) | 18 months | All randomized patients excluding late screen failures | Time to culture negative status / weeks | MEDIAN |
| SECONDARY | Sensitivity Analysis Assuming All Losses to Follow-up and Non-tuberculous Deaths Have an Unfavorable Outcome Using Solid (L-J) Media. | 18 months | All randomized subjects. | participants with unfavorable outcome | NUMBER |
| SECONDARY | Sensitivity Analyses Assuming All Losses to Follow-up and Non-tuberculous Deaths Have a Favourable Outcome Using Solid (L-J) Media. | 18 months | participants with unfavorable outcome | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ). | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 43 | participants with failure or relapse | ||
| Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ). | Regimen 2 - 2MHRZ/2MHR | 78 | participants with failure or relapse | ||
| Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy as Defined by Culture Using Solid Media (Lowenstein-Jensen - LJ). | Regimen 3 - 2EMRZ/2MR | 105 | participants with failure or relapse | ||
Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting) | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 123 | participants with Grade 3 or 4 AEs | ||
Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting) | Regimen 2 - 2MHRZ/2MHR | 127 | participants with Grade 3 or 4 AEs | ||
Number of Patients With Grade 3 or 4 Adverse Events (Using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases [DAIDS] Scale of Adverse Event Reporting) | Regimen 3 - 2EMRZ/2MR | 111 | participants with Grade 3 or 4 AEs | ||
| Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT). | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 65 | participants with failure or relapse | ||
| Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT). | Regimen 2 - 2MHRZ/2MHR | 98 | participants with failure or relapse | ||
| Combined Failure of Bacteriological Cure and Relapse as Defined by Culture Using Liquid Media (Mycobacteria Growth Indicator Tube-MGIT). | Regimen 3 - 2EMRZ/2MR | 131 | participants with failure or relapse | ||
| Number of Patients Who Are Culture Negative (Solid LJ Culture) | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 352 | participants who are culture negative |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Per- Protocol | STARTED | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 640 | |
| Per- Protocol | STARTED | Regimen 2 - 2MHRZ/2MHR | 655 | |
| Per- Protocol | STARTED | Regimen 3 - 2EMRZ/2MR | 636 | |
| Per- Protocol | COMPLETED | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 510 | |
| Per- Protocol | COMPLETED | Regimen 2 - 2MHRZ/2MHR | 514 | |
| Per- Protocol | COMPLETED | Regimen 3 - 2EMRZ/2MR | 524 | |
| Per- Protocol | NOT COMPLETED | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 130 | |
| Per- Protocol | NOT COMPLETED | Regimen 2 - 2MHRZ/2MHR | 141 | |
| Per- Protocol | NOT COMPLETED | Regimen 3 - 2EMRZ/2MR | 112 | |
| Modified Intent to Treat | STARTED | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 640 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2,064
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 | Abdominal Lymphadenopathy | Blood and lymphatic system disorders | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 0 | 639 | 0 |
| other | Abdominal Lymphadenopathy | Blood and lymphatic system disorders | Regimen 2 - 2MHRZ/2MHR | 1 | 655 | 2 |
| other | Abdominal Lymphadenopathy | Blood and lymphatic system disorders | Regimen 3 - 2EMRZ/2MR | 0 | 636 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 10 | 639 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Regimen 2 - 2MHRZ/2MHR | 13 | 655 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Regimen 3 - 2EMRZ/2MR | 8 | 636 | 11 |
| other | Hypochromic Anaemia | Blood and lymphatic system disorders | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 1 | 639 | 1 |
| other | Hypochromic Anaemia | Blood and lymphatic system disorders | Regimen 2 - 2MHRZ/2MHR | 0 | 655 | 0 |
| other | Hypochromic Anaemia | Blood and lymphatic system disorders | Regimen 3 - 2EMRZ/2MR | 0 | 636 | 0 |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 0 | 639 | 0 |
1 to 10 of 2,064Source ClinicalTrials.gov
See all 2,064 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen 1 - 2EHRZ/4HR (Control Regimen) | ||
| Total, all-cause mortality | Regimen 2 - 2MHRZ/2MHR | ||
| Total, all-cause mortality | Regimen 3 - 2EMRZ/2MR | ||
| Total, other adverse events | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 507 | 639 |
| Total, other adverse events | Regimen 2 - 2MHRZ/2MHR | 537 | 655 |
| Total, other adverse events | Regimen 3 - 2EMRZ/2MR | 522 | 636 |
| Total, serious adverse events | Regimen 1 - 2EHRZ/4HR (Control Regimen) | 38 | 639 |
| Total, serious adverse events | Regimen 2 - 2MHRZ/2MHR | 46 | 655 |
| Total, serious adverse events | Regimen 3 - 2EMRZ/2MR | 40 | 636 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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.
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