Comparison · NCT03338621-3b3cdcef
Drug Sensitive-TB 2HRZE/4HR vs Drug Sensitive-TB 4BPaMZ: Number of Participants With Culture Negative Status by 8 Weeks
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Drug Sensitive-TB 2HRZE/4HR vs Drug Sensitive-TB 4BPaMZ: Number of Participants With Culture Negative Status by 8 Weeks. Trial comparisons, record NCT03338621-3b3cdcef. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03338621-3b3cdcef
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.473 | 0.394 | 0.553 | wilson | |
| Risk in group 2 | 0.841 | 0.773 | 0.892 | wilson | |
| Risk difference, group 1 minus group 2 | -0.368 | -0.462 | -0.263 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.562 | 0.468 | 0.676 | log | |
| Odds ratio, group 1 over group 2 | 0.169 | 0.0976 | 0.293 | log | |
| Number needed to treat, for one fewer participant with the outcome on Drug Sensitive-TB 2HRZE/4HR than on Drug Sensitive-TB 4BPaMZ | 2.71 | 2.16 | 3.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Drug Sensitive-TB 2HRZE/4HR | isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg (HRZE) combination tablets for 8 weeks AND isoniazid 75 mg + rifampicin 150 mg (HR) combination tablets for Weeks 9 to 26~HRZE: isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets~HR: isoniazid 75 mg plus rifampicin 150 mg combination tablets~Participant Dosage based on weight | 70 | 148 | OG000 |
| Group 2 | Drug Sensitive-TB 4BPaMZ | Bedaquiline 200 mg daily for 8 weeks then 100 mg daily for 9 weeks, together with pretomanid 200 mg + moxifloxacin 400 mg + pyrazinamide 1500 mg daily for 17 weeks (Total treatment duration 4 months)~Pretomanid: 200 mg tablets~Bedaquiline: 100 mg tablets~Moxifloxacin: 400 mg tablets~Pyrazinamide: 500 mg tablets | 122 | 145 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Culture Negative Status by 8 Weeks
- Description
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.
- Time frame
- Days 0-56 (8 weeks)
- Population
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.
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE2, PHASE3
- Conditions
- Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant, Tuberculosis, MDR, Tuberculosis, Drug-Resistant Tuberculosis
- Interventions
- Pretomanid, Bedaquiline, Moxifloxacin, Pyrazinamide, HRZE, HR
- Lead sponsor
- Global Alliance for TB Drug Development
- Results first posted
- 2023-11-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03338621?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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