Trial · NCT02066402
Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
NCT02066402, Phase 3, Completed, Bayer; results first posted 2017-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI). Trials, record NCT02066402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02066402
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
- NCT number
- NCT02066402
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 598 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Bacterial Infections
- Interventions
- Tedizolid (BAY119-2631), Placebo Tedizolid (BAY119-2631), Linezolid, Placebo Linezolid
- First posted
- 2014-02-19
- Last updated
- 2017-06-07
- Results first posted
- 2017-06-07
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | Baseline and 48-72 hours visit | Early clinical response is defined as responder if there is \>=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit. |
| Secondary | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Baseline and EOT visit (Day 11) | Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48-72 H Visit. |
| Secondary | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Baseline and EOT visit (Day 11) | Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate. |
| Secondary | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | Baseline and post-therapy evaluation visit (7-14 days after Day 11) | The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported. |
| Secondary | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | Baseline and post-therapy evaluation visit (7-14 days after Day 11) | The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported. |
| Secondary | Investigator's Assessment of Clinical Response at 48-72 Hours | Baseline and at 48-72 hours | The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other. |
| Secondary | Investigator's Assessment of Clinical Response at Day 7 Visit | Baseline and Day 7 visit | The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other. |
| Secondary | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. |
| Secondary | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value. |
| Secondary | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | Baseline and 48-72 hours visit | ITT | Percentage of participants | NUMBER |
| SECONDARY | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Baseline and EOT visit (Day 11) | ITT | Percentage of participants | NUMBER |
| SECONDARY | Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Baseline and EOT visit (Day 11) | CE-EOT | Percentage of participants | NUMBER |
| SECONDARY | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set | Baseline and post-therapy evaluation visit (7-14 days after Day 11) | ITT | Percentage of participants | NUMBER |
| SECONDARY | Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set | Baseline and post-therapy evaluation visit (7-14 days after Day 11) | CE-PTE | Percentage of participants | NUMBER |
| SECONDARY | Investigator's Assessment of Clinical Response at 48-72 Hours | Baseline and at 48-72 hours | ITT | Percentage of participants | NUMBER |
| SECONDARY | Investigator's Assessment of Clinical Response at Day 7 Visit | Baseline and Day 7 visit | ITT | Percentage of participants | NUMBER |
| SECONDARY | Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | ITT | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | ITT | Units on a scale | MEAN |
| SECONDARY | Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point | Up to EOT visit (Day 11) | ITT | Units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | Tedizolid Phosphate (Sivextro, BAY119-2631) | 75.3 | Percentage of participants | ||
| Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. | Linezolid | 79.9 | Percentage of participants | ||
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Tedizolid Phosphate (Sivextro, BAY119-2631) | Clinical success | 82.0 | Percentage of participants | |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Linezolid | Clinical success | 84.2 | Percentage of participants | |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Tedizolid Phosphate (Sivextro, BAY119-2631) | Clinical failure or Indeterminate | 18.0 | Percentage of participants | |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set | Linezolid | Clinical failure or Indeterminate | 15.8 | Percentage of participants | |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Tedizolid Phosphate (Sivextro, BAY119-2631) | Clinical success | 89.7 | Percentage of participants | |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Linezolid | Clinical success | 91.8 | Percentage of participants | |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Tedizolid Phosphate (Sivextro, BAY119-2631) | Clinical failure or Indeterminate | 10.3 | Percentage of participants | |
| Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set | Linezolid | Clinical failure or Indeterminate | 8.2 | Percentage of participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tedizolid Phosphate (Sivextro, BAY119-2631) | 300 | |
| Overall Study | STARTED | Linezolid | 298 | |
| Overall Study | Participants Received Treatment | Tedizolid Phosphate (Sivextro, BAY119-2631) | 292 | |
| Overall Study | Participants Received Treatment | Linezolid | 297 | |
| Overall Study | Completed Study Treatment Period | Tedizolid Phosphate (Sivextro, BAY119-2631) | 261 | |
| Overall Study | Completed Study Treatment Period | Linezolid | 256 | |
| Overall Study | COMPLETED | Tedizolid Phosphate (Sivextro, BAY119-2631) | 274 | |
| Overall Study | COMPLETED | Linezolid | 275 | |
| Overall Study | NOT COMPLETED | Tedizolid Phosphate (Sivextro, BAY119-2631) | 26 | |
| Overall Study | NOT COMPLETED | Linezolid | 23 |
Source ClinicalTrials.gov
Adverse events60
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 | Diarrhoea | Gastrointestinal disorders | Tedizolid Phosphate (Sivextro, BAY119-2631) | 7 | 292 | |
| other | Diarrhoea | Gastrointestinal disorders | Linezolid | 8 | 297 | |
| other | Nausea | Gastrointestinal disorders | Tedizolid Phosphate (Sivextro, BAY119-2631) | 15 | 292 | |
| other | Nausea | Gastrointestinal disorders | Linezolid | 14 | 297 | |
| other | Fatigue | General disorders | Tedizolid Phosphate (Sivextro, BAY119-2631) | 3 | 292 | |
| other | Fatigue | General disorders | Linezolid | 6 | 297 | |
| other | Injection site extravasation | General disorders | Tedizolid Phosphate (Sivextro, BAY119-2631) | 5 | 292 | |
| other | Injection site extravasation | General disorders | Linezolid | 6 | 297 | |
| other | Pyrexia | General disorders | Tedizolid Phosphate (Sivextro, BAY119-2631) | 10 | 292 | |
| other | Pyrexia | General disorders | Linezolid | 5 | 297 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tedizolid Phosphate (Sivextro, BAY119-2631) | ||
| Total, all-cause mortality | Linezolid | ||
| Total, other adverse events | Tedizolid Phosphate (Sivextro, BAY119-2631) | 60 | 292 |
| Total, other adverse events | Linezolid | 63 | 297 |
| Total, serious adverse events | Tedizolid Phosphate (Sivextro, BAY119-2631) | 11 | 292 |
| Total, serious adverse events | Linezolid | 8 | 297 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30988146 | DERIVED |
Source PubMed
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, BAY119-2631) 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/NCT02066402
GET https://conductscience.org/api/trials/v1/NCT02066402/results?page=2