Trial · NCT01967225
Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections
NCT01967225, Phase 3, Completed, Bayer; results first posted 2018-10-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections. Trials, record NCT01967225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01967225
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections
- NCT number
- NCT01967225
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 125 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Skin Diseases, Infectious
- Interventions
- Tedizolid Phosphate (Sivextro, BAY1192631), Linezolid
- First posted
- 2013-10-22
- Last updated
- 2018-10-04
- Results first posted
- 2018-10-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response at Test of Cure (TOC) | 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia | Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count. |
| Primary | Microbiological Response at Test of Cure (TOC) | 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia | Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society. |
| Secondary | Clinical Response at End of Treatment Visit (EOT) | 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration | Clinical response was evaluated by the masked investigator as effective, ineffective and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count. |
| Secondary | Microbiological Response at End of Treatment (EOT) | 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration | Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society. |
| Secondary | Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI]) | Multiple time points up to 7-14 days after the end of treatment | Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest. |
| Secondary | Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI]) | Baseline and Day 3/4, Day 5/13, EOT, TOC | Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest. Reduction ratio (%) = 100 \* (the post baseline value - baseline value) / baseline value. Negative values represent reduction of lesion size compared to baseline. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response at Test of Cure (TOC) | 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia | This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. | Percentage of participants | NUMBER |
| PRIMARY | Microbiological Response at Test of Cure (TOC) | 7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia | This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Response at End of Treatment Visit (EOT) | 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration | This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. | Percentage of participants | NUMBER |
| SECONDARY | Microbiological Response at End of Treatment (EOT) | 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration | This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. | Percentage of participants | NUMBER |
| SECONDARY | Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI]) | Multiple time points up to 7-14 days after the end of treatment | This outcome measure was analyzed based on the microbiological evaluable population-ME-MRSA analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. Data of SSTI target participants were reported for this outcome measure. | cm^2 | MEAN |
| SECONDARY | Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI]) | Baseline and Day 3/4, Day 5/13, EOT, TOC | This outcome measure was analyzed based on the microbiological evaluable population-ME-MRSA analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. Data of SSTI target participants were reported for this outcome measure. | Percentage | MEAN |
Source ClinicalTrials.gov
Results by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response at Test of Cure (TOC) | Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI | Clinical cure | 86.2 | 75.7 to 99.1 | Percentage of participants |
| Clinical Response at Test of Cure (TOC) | Linezoid - SSTI | Clinical cure | 80.0 | Percentage of participants | |
| Clinical Response at Test of Cure (TOC) | Linezoid - Bacteremia | Clinical cure | 0.0 | Percentage of participants | |
| Clinical Response at Test of Cure (TOC) | Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI | Clinical failure | 6.9 | Percentage of participants | |
| Clinical Response at Test of Cure (TOC) | Linezoid - SSTI | Clinical failure | 10.0 | Percentage of participants | |
| Clinical Response at Test of Cure (TOC) | Linezoid - Bacteremia | Clinical failure | 0.0 | Percentage of participants | |
| Clinical Response at Test of Cure (TOC) | Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI | Indeterminate | 6.9 | Percentage of participants | |
| Clinical Response at Test of Cure (TOC) | Linezoid - SSTI | Indeterminate | 10.0 | Percentage of participants | |
| Clinical Response at Test of Cure (TOC) | Linezoid - Bacteremia | Indeterminate | 100.0 | Percentage of participants | |
| Microbiological Response at Test of Cure (TOC) | Tedizolid Phosphate (Sivextro, BAY1192631) - SSTI | Eradication | 93.1 | Percentage of participants |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tedizolid Phosphate (Sivextro, BAY1192631) | 84 | |
| Overall Study | STARTED | Linezolid | 41 | |
| Overall Study | Participants Received Treatment | Tedizolid Phosphate (Sivextro, BAY1192631) | 83 | |
| Overall Study | Participants Received Treatment | Linezolid | 41 | |
| Overall Study | COMPLETED | Tedizolid Phosphate (Sivextro, BAY1192631) | 72 | |
| Overall Study | COMPLETED | Linezolid | 38 | |
| Overall Study | NOT COMPLETED | Tedizolid Phosphate (Sivextro, BAY1192631) | 12 | |
| Overall Study | NOT COMPLETED | Linezolid | 3 |
Source ClinicalTrials.gov
Adverse events288
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 | Tedizolid Phosphate (Sivextro, BAY1192631) | 1 | 83 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Linezolid | 2 | 41 | 2 |
| other | Eosinophilia | Blood and lymphatic system disorders | Tedizolid Phosphate (Sivextro, BAY1192631) | 0 | 83 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Linezolid | 1 | 41 | 1 |
| other | Pancytopenia | Blood and lymphatic system disorders | Tedizolid Phosphate (Sivextro, BAY1192631) | 0 | 83 | 0 |
| other | Pancytopenia | Blood and lymphatic system disorders | Linezolid | 1 | 41 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tedizolid Phosphate (Sivextro, BAY1192631) | 0 | 83 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Linezolid | 2 | 41 | 2 |
| other | Bone marrow failure | Blood and lymphatic system disorders | Tedizolid Phosphate (Sivextro, BAY1192631) | 0 | 83 | 0 |
| other | Bone marrow failure | Blood and lymphatic system disorders | Linezolid | 1 | 41 | 1 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tedizolid Phosphate (Sivextro, BAY1192631) | ||
| Total, all-cause mortality | Linezolid | ||
| Total, other adverse events | Tedizolid Phosphate (Sivextro, BAY1192631) | 64 | 83 |
| Total, other adverse events | Linezolid | 31 | 41 |
| Total, serious adverse events | Tedizolid Phosphate (Sivextro, BAY1192631) | 7 | 83 |
| Total, serious adverse events | Linezolid | 4 | 41 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tedizolid Phosphate (Sivextro, BAY1192631) vs Linezolid: serious adverse events |
Source 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/NCT01967225
GET https://conductscience.org/api/trials/v1/NCT01967225/results?page=2