Trial · NCT01170221
TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
NCT01170221, Phase 3, Completed, Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2014-09-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections. Trials, record NCT01170221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01170221
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
- NCT number
- NCT01170221
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 667 participants, actual
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Skin and Subcutaneous Tissue Bacterial Infections
- Interventions
- TR-701 FA, Linezolid
- First posted
- 2010-07-27
- Last updated
- 2018-08-29
- Results first posted
- 2014-09-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Early Clinical Response Rate | 48-72 hours | Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C |
| Secondary | Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit. | Day 11 | Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C. |
| Secondary | Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets | EOT Day 11 | Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C |
| Secondary | Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit | Post-Treatment Evaluation (7-14 days after the End of Therapy) | Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion. |
| Secondary | To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set | Post-Treatment Evaluation (7-14 days after the End of Therapy) | Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion. |
| Secondary | Investigator's Assessment of Clinical Response at the 48-72 Hour Visit | 48-72 Hour Visit | Clinical improvement was defined as improvement in overall clinical status. |
| Secondary | Investigator's Assessment of Clinical Response at the Day 7 Visit | Day 7 | Clinical improvement was defined as improvement in overall clinical status. |
| Secondary | Change From Baseline in Patient-reported Pain, by Study Visit | Multiple | 0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Early Clinical Response Rate | 48-72 hours | The ITT analysis set includes data from all randomized participants. | Responders | NUMBER |
| SECONDARY | Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit. | Day 11 | The ITT analysis set includes data from all randomized participants. | participants | NUMBER |
| SECONDARY | Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets | EOT Day 11 | All randomized patients receiving minimal study therapy, completed 48-72 Hour and EOT assessments, no concomitant systemic antibiotic therapy through EOT, and had no confounding events or factors | participants | NUMBER |
| SECONDARY | Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit | Post-Treatment Evaluation (7-14 days after the End of Therapy) | The Intent to Treat analysis set included data from all randomized participants. | participants | NUMBER |
| SECONDARY | To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set | Post-Treatment Evaluation (7-14 days after the End of Therapy) | All randomized patients who received the minimal study therapy, completed EOT and PTE assessments, no concomitant systemic antibiotic therapy through PTE, and had no confounding events or factors. | participants | NUMBER |
| SECONDARY | Investigator's Assessment of Clinical Response at the 48-72 Hour Visit | 48-72 Hour Visit | The Intent to Treat analysis set includes data from all randomized participants. | participants | NUMBER |
| SECONDARY | Investigator's Assessment of Clinical Response at the Day 7 Visit | Day 7 | The Intent to Treat analysis set includes data from all randomized participants. | participants | NUMBER |
| SECONDARY | Change From Baseline in Patient-reported Pain, by Study Visit | Multiple | The Intent to Treat analysis set includes data from all randomized participants. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Early Clinical Response Rate | Tedizolid Phosphate | 264 | -6.1 to 6.2 | Responders | |
| Early Clinical Response Rate | Linezolid | 266 | -6.1 to 6.2 | Responders | |
| Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit. | Tedizolid Phosphate | 230 | participants | ||
| Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit. | Linezolid | 241 | participants | ||
| Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets | Tedizolid Phosphate | 219 | participants | ||
| Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets | Linezolid | 232 | participants | ||
| Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit | Tedizolid Phosphate | 284 | participants | ||
| Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit | Linezolid | 288 | participants | ||
| To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set | Tedizolid Phosphate | 264 | participants | ||
| To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set | Linezolid | 267 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tedizolid Phosphate | 332 | |
| Overall Study | STARTED | Linezolid | 335 | |
| Overall Study | COMPLETED | Tedizolid Phosphate | 299 | |
| Overall Study | COMPLETED | Linezolid | 307 | |
| Overall Study | NOT COMPLETED | Tedizolid Phosphate | 33 | |
| Overall Study | NOT COMPLETED | Linezolid | 28 |
Source ClinicalTrials.gov
Adverse events50
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 | Nausea | Gastrointestinal disorders | Tedizolid Phosphate | 28 | 331 | |
| other | Nausea | Gastrointestinal disorders | Linezolid | 45 | 335 | |
| other | Headache | Nervous system disorders | Tedizolid Phosphate | 21 | 331 | |
| other | Headache | Nervous system disorders | Linezolid | 17 | 335 | |
| other | Diarrhea | Gastrointestinal disorders | Tedizolid Phosphate | 15 | 331 | |
| other | Diarrhea | Gastrointestinal disorders | Linezolid | 18 | 335 | |
| other | Abscess | Infections and infestations | Tedizolid Phosphate | 14 | 331 | |
| other | Abscess | Infections and infestations | Linezolid | 8 | 335 | |
| other | Abscess limb | Infections and infestations | Tedizolid Phosphate | 12 | 331 | |
| other | Abscess limb | Infections and infestations | Linezolid | 10 | 335 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tedizolid Phosphate | ||
| Total, all-cause mortality | Linezolid | ||
| Total, other adverse events | Tedizolid Phosphate | 84 | 331 |
| Total, other adverse events | Linezolid | 100 | 335 |
| Total, serious adverse events | Tedizolid Phosphate | 5 | 331 |
| Total, serious adverse events | Linezolid | 4 | 335 |
Source ClinicalTrials.gov
Papers7
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tedizolid Phosphate vs Linezolid: Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit | Trial comparisons |
| Tedizolid Phosphate vs Linezolid: Investigator's Assessment of Clinical Response at the 48-72 Hour Visit | Trial comparisons |
| Tedizolid Phosphate vs Linezolid: Investigator's Assessment of Clinical Response at the Day 7 Visit | Trial comparisons |
| Tedizolid Phosphate vs Linezolid: Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit. | Trial comparisons |
| Tedizolid Phosphate vs Linezolid: Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets | Trial comparisons |
| Tedizolid Phosphate vs Linezolid: To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set | Trial comparisons |
| Tedizolid Phosphate vs Linezolid: 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/NCT01170221
GET https://conductscience.org/api/trials/v1/NCT01170221/results?page=2