Trial · NCT02153528
Optimization of the TB Treatment Regimen Cascade
NCT02153528, Phase 3, Completed, Damien Foundation; results first posted 2020-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Optimization of the TB Treatment Regimen Cascade. Trials, record NCT02153528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02153528
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimization of the TB Treatment Regimen Cascade
- NCT number
- NCT02153528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 701 participants, actual
- Lead sponsor
- Damien Foundation
- Conditions
- Tuberculosis, Pulmonary
- Interventions
- double rimfampicin, Standard TB treatment
- First posted
- 2014-06-03
- Last updated
- 2020-02-13
- Results first posted
- 2020-02-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tuberculose Treatment Outcome | 12 months after end of treatment | Following current WHO guidelines, an adverse treatment outcome is defined as any occurrence of the following: * Relapse: Cured previously from TB or completed treatment for TB and now having bacteriologically positive sputum for TB (at 12 months follow-up or at an earlier time point) * Default: The patient whose treatment was interrupted for ≥ 2 consecutive months. * Failure: Sputum positive for TB at 5 months or later during treatment. In line with current WHO recommendations, patients detected with MDR-TB or rifampicin resistance before this or another outcome applies and switched to the MDR-TB regimen will be excluded from the outcome analysis.18 Failure will also be declared if the regimen has to be changed for at least 2 drugs due to adverse events. * Death: All-cause mortality between case registration and end of TB treatment (related or not to TB or TB treatment) |
| Primary | Number of Participants Who Develop Liver Toxicity | until month eight | Grade 3-4 Liver Toxicity following NIH common toxicity criteria (CTC), including transaminase increases to \>5-20 ULN (grade 3), or \> 20 ULN (grade 4) |
| Secondary | High-level Rifampicin Resistant TB Adverse Treatment Outcomes | 12 months after end of TB treatment | To assess whether the study regimen also cures high-level rifampicin resistant TB. Adverse treatment outcomes will be described and compared among treatment groups in subgroups defined by initial rifampicin resistance mutations (performed in all patients) detected. |
| Secondary | Number of Initial Resistant TB Cases Who Switched to MDR-TB Treatment or Were Cured | at two weeks of treatment | To assess the effectiveness of FDA vital staining versus fever screening for early switch of non-responding rifampicin resistant TB to MDR-TB treatment |
| Secondary | the Negative Predictive Value of Conversion at 2 Weeks for Relapse. | at 2 weeks of treatment | The Negative Predictive value (and 95% CI) of conversion in the intervention arm will be estimated as the % of relapses among those with a minimum 1 log decline in the number of AFB, or who are already negative or only scanty positive on AFB smear (auramine or FDA). |
| Secondary | Proportion of Acquired Rifampicin Resistance Among Failures and Relapses | 12 months after end of TB treatment | number of failure / relapse cases without mutation detected at diagnosis as the denominator and comparing intervention and control arms. |
| Secondary | Area Under the Curve of Auramine Resp. FDA at 2 Weeks to Predict Adverse Treatment Outcome at 1 Year After Treatment Completion | Auramine/FDA at 2 weeks and adverse treatment outcome 1 year after treatment completion | Area under the ROC curve (AUC) to predict adverse treatment outcome. The X-axis represents the 1-specificity, the Y-axis represents sensitivity. The AUC is estimated with 95% confidence interval. |
| Secondary | Weight Gain | until end of treatment (month eight) | Weight gain from baseline until end-of-treatment comparison between both treatment arms. |
| Secondary | Fever Resolution | after 2 weeks of treatment | Comparison of fever resolution after 2 weeks of treatment between both treatment arms. |
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 | Tuberculose Treatment Outcome | 12 months after end of treatment | Intention-to-treat analysis. Additional 4 subjects were removed from the ITT analysis because they switched to MDR regimen (3 in control arm, 1 in intervention arm). 4 subjects (intervention arm) were removed from the ITT analysis because they were enrolled twice. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Develop Liver Toxicity | until month eight | One participant was allocated to double rifampicin arm but received standard TB treatment, and was analysed in the standard TB treatment arm.Two participants were deleted from analysis because they had grade 3 liver toxicity at baseline and 6 participants were deleted because they did not have any follow-up ALT values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | High-level Rifampicin Resistant TB Adverse Treatment Outcomes | 12 months after end of TB treatment | ITT analysis population. Compared to analysis population of primary objective - TB treatment outcome, 24 subjects were excluded from this analysis due to missing or negative sequencing results (8 in control group, 16 in intervention group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Initial Resistant TB Cases Who Switched to MDR-TB Treatment or Were Cured | at two weeks of treatment | 7 initial resistant cases (5 in control group and 2 in intervention group). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | the Negative Predictive Value of Conversion at 2 Weeks for Relapse. | at 2 weeks of treatment | ITT analysis. This analysis only includes participants in the intervention arm who are negative on auramine smear resp. FDA smear at 2 weeks. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Acquired Rifampicin Resistance Among Failures and Relapses | 12 months after end of TB treatment | ITT analysis. This analysis only includes failure / relapse cases without mutation detected at diagnosis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Curve of Auramine Resp. FDA at 2 Weeks to Predict Adverse Treatment Outcome at 1 Year After Treatment Completion | Auramine/FDA at 2 weeks and adverse treatment outcome 1 year after treatment completion | no unit is used for AUROC | NUMBER | |
| SECONDARY | Weight Gain | until end of treatment (month eight) | kg | MEAN | |
| SECONDARY | Fever Resolution | after 2 weeks of treatment | Total of participants with fever at baseline. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tuberculose Treatment Outcome | Standard TB Treatment | Default | 8 | Participants | |
| Tuberculose Treatment Outcome | Double Rimfampicin | Default | 8 | Participants | |
| Tuberculose Treatment Outcome | Standard TB Treatment | Died | 11 | Participants | |
| Tuberculose Treatment Outcome | Double Rimfampicin | Died | 5 | Participants | |
| Tuberculose Treatment Outcome | Standard TB Treatment | Failure | 8 | Participants | |
| Tuberculose Treatment Outcome | Double Rimfampicin | Failure | 12 | Participants | |
| Tuberculose Treatment Outcome | Standard TB Treatment | Completed | 6 | Participants | |
| Tuberculose Treatment Outcome | Double Rimfampicin | Completed | 3 | Participants | |
| Tuberculose Treatment Outcome | Standard TB Treatment | Cured | 310 | Participants | |
| Tuberculose Treatment Outcome | Double Rimfampicin | Cured | 319 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard TB Treatment | 348 | |
| Overall Study | STARTED | Double Rimfampicin | 353 | |
| Overall Study | COMPLETED | Standard TB Treatment | 348 | |
| Overall Study | COMPLETED | Double Rimfampicin | 353 | |
| Overall Study | NOT COMPLETED | Standard TB Treatment | 0 | |
| Overall Study | NOT COMPLETED | Double Rimfampicin | 0 |
Source ClinicalTrials.gov
Adverse events40
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 |
|---|---|---|---|---|---|---|
| serious | Cardiopulmonary failure | Cardiac disorders | Standard TB Treatment | 1 | 348 | |
| serious | Cardiopulmonary failure | Cardiac disorders | Double Rimfampicin | 1 | 353 | |
| serious | Abdominal pain | Gastrointestinal disorders | Standard TB Treatment | 1 | 348 | |
| serious | Abdominal pain | Gastrointestinal disorders | Double Rimfampicin | 0 | 353 | |
| serious | Vomiting | Gastrointestinal disorders | Standard TB Treatment | 2 | 348 | |
| serious | Vomiting | Gastrointestinal disorders | Double Rimfampicin | 0 | 353 | |
| serious | Asthenia | General disorders | Standard TB Treatment | 0 | 348 | |
| serious | Asthenia | General disorders | Double Rimfampicin | 1 | 353 | |
| serious | Hepatitis | Hepatobiliary disorders | Standard TB Treatment | 2 | 348 | |
| serious | Hepatitis | Hepatobiliary disorders | Double Rimfampicin | 1 | 353 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard TB Treatment | 17 | 348 |
| Total, all-cause mortality | Double Rimfampicin | 12 | 353 |
| Total, other adverse events | Standard TB Treatment | 0 | 348 |
| Total, other adverse events | Double Rimfampicin | 0 | 353 |
| Total, serious adverse events | Standard TB Treatment | 24 | 348 |
| Total, serious adverse events | Double Rimfampicin | 13 | 353 |
Source ClinicalTrials.gov
Papers0
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard TB Treatment vs Double Rimfampicin: Number of Initial Resistant TB Cases Who Switched to MDR-TB Treatment or Were Cured | Trial comparisons |
| Standard TB Treatment vs Double Rimfampicin: Number of Participants Who Develop Liver Toxicity | Trial comparisons |
| Standard TB Treatment vs Double Rimfampicin: Proportion of Acquired Rifampicin Resistance Among Failures and Relapses | Trial comparisons |
| Standard TB Treatment vs Double Rimfampicin: deaths from any cause | Trial comparisons |
| Double Rifampicin Arm Negative on Auramine Smear vs Double Rifampicin Group Negative on FDA Smear: the Negative Predictive Value of Conversion at 2 Weeks for Relapse. | Trial comparisons |
| Standard TB Treatment vs Double Rimfampicin: Fever Resolution | Trial comparisons |
| Standard TB Treatment vs Double Rimfampicin: serious adverse events | 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/NCT02153528
GET https://conductscience.org/api/trials/v1/NCT02153528/results?page=2