Trial · NCT02114684
Improving Retreatment Success (IMPRESS)
NCT02114684, Phase 1, Phase 2, Completed, Centre for the AIDS Programme of Research in South Africa; results first posted 2019-08-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Retreatment Success (IMPRESS). Trials, record NCT02114684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02114684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Retreatment Success (IMPRESS)
- NCT number
- NCT02114684
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 197 participants, actual
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Conditions
- Recurrent Tuberculosis
- Interventions
- moxifloxacin
- First posted
- 2014-04-15
- Last updated
- 2019-08-05
- Results first posted
- 2019-08-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation | 24 weeks | The proportion of patients with negative sputum cultures at the end of the intensive phase (8 weeks) and the proportion of patients with negative sputum cultures at 6 months were compared between the two study arms. All participants with sputum culture results at week 8 and month 6 were included in the analysis. |
| Secondary | Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen | Up to 2 years | To determine the time to culture-conversion of the moxifloxacin regimen and the ethambutol regimen. |
| Secondary | Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms | Up to 2 years | To compare the proportion of patients with any Grade 3 or 4 adverse reactions in the two study arms. Outcome measured in terms of number of participants with at least one grade 3 or 4 events, and not in number of events. |
| Secondary | Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients | up to 2 years for adverse events and 8 weeks for culture conversion rates | To compare adverse events and 8-week culture conversion rates among HIV-infected patients vs. HIV-uninfected patients. The proportion of participants with at least one grade 3 or 4 adverse event was measured. |
| Secondary | Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm. | up to 2 years | A patient was defined as having an unfavourable outcome if he/she was not cured at the end of treatment or did not successfully complete treatment. Recurrence after completion of treatment was defined as two positive cultures within a period of four months without an intervening negative culture. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation | 24 weeks | Nine participants had missing data at week 8: 4 missed visits, 3 terminated before week 8 and 2 had MOTT cultured. Fourteen had missing data at month 6: 7 were terminated before month 6 and 7 missed their visits. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen | Up to 2 years | weeks | MEDIAN | |
| SECONDARY | Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients | up to 2 years for adverse events and 8 weeks for culture conversion rates | 9 participants had missing data at 8 weeks: 4 missed visits, 3 terminated before week 8, and 2 had MOTT cultured | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm. | up to 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation | Moxifloxacin | culture negative at 8 weeks | 78 | Participants | |
| Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation | Control | culture negative at 8 weeks | 73 | Participants | |
| Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation | Moxifloxacin | culture negative at 6 months | 84 | Participants | |
| Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation | Control | culture negative at 6 months | 92 | Participants | |
| Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen | Moxifloxacin | 6.0 | Inter-Quartile Range 4.0 to 8.3 | weeks | |
| Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen | Control | 7.9 | Inter-Quartile Range 4.0 to 11.4 | weeks | |
| Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms | Moxifloxacin | 43 | Participants | ||
| Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms | Control | 25 | Participants | ||
| Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients | HIV Positive, Moxifloxacin | participants with grade 3/4 adverse events | 30 | Participants | |
| Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients | HIV Positive, Control | participants with grade 3/4 adverse events | 19 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Moxifloxacin | 98 | |
| Overall Study | STARTED | Control | 98 | |
| Overall Study | COMPLETED | Moxifloxacin | 86 | |
| Overall Study | COMPLETED | Control | 88 | |
| Overall Study | NOT COMPLETED | Moxifloxacin | 12 | |
| Overall Study | NOT COMPLETED | Control | 10 |
Source ClinicalTrials.gov
Adverse events202
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 | Anaemia | Blood and lymphatic system disorders | Moxifloxacin | 2 | 98 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Control | 1 | 98 | 1 |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Moxifloxacin | 1 | 98 | 1 |
| other | Normochromic normocytic anaemia | Blood and lymphatic system disorders | Control | 0 | 98 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Moxifloxacin | 1 | 98 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Control | 0 | 98 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Moxifloxacin | 1 | 98 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Control | 0 | 98 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Moxifloxacin | 6 | 98 | 7 |
| other | Neutropenia | Blood and lymphatic system disorders | Control | 2 | 98 | 2 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Moxifloxacin | 6 | 98 |
| Total, all-cause mortality | Control | 4 | 98 |
| Total, other adverse events | Moxifloxacin | 30 | 98 |
| Total, other adverse events | Control | 19 | 98 |
| Total, serious adverse events | Moxifloxacin | 27 | 98 |
| Total, serious adverse events | Control | 12 | 98 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Moxifloxacin vs Control: Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms | Trial comparisons |
| Moxifloxacin vs Control: deaths from any cause | Trial comparisons |
| Moxifloxacin vs Control: Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm. | Trial comparisons |
| Moxifloxacin vs Control: 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/NCT02114684
GET https://conductscience.org/api/trials/v1/NCT02114684/events?page=2