Trial · NCT01519778
A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study
NCT01519778, Phase 2, Completed, Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2015-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study. Trials, record NCT01519778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01519778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study
- NCT number
- NCT01519778
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 200 participants, actual
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Major Cutaneous Abscess, Cellulitis, Erysipelas
- Interventions
- TR701 FA
- First posted
- 2012-01-27
- Last updated
- 2018-08-29
- Results first posted
- 2015-03-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 24-31 days | Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 24-31 days | Patients receiving any amount of study drug | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | TR-701 FA | 91 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TR-701 FA | 200 | |
| Overall Study | COMPLETED | TR-701 FA | 186 | |
| Overall Study | NOT COMPLETED | TR-701 FA | 14 |
Source ClinicalTrials.gov
Adverse events12
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 | TR-701 FA | 22 | 200 | |
| other | diarrhea | Gastrointestinal disorders | TR-701 FA | 13 | 200 | |
| other | cellulitis | Infections and infestations | TR-701 FA | 10 | 200 | |
| other | abscess | Infections and infestations | TR-701 FA | 9 | 200 | |
| other | vomiting | Gastrointestinal disorders | TR-701 FA | 9 | 200 | |
| other | dizziness | Nervous system disorders | TR-701 FA | 7 | 200 | |
| other | headache | Nervous system disorders | TR-701 FA | 7 | 200 | |
| other | chills | General disorders | TR-701 FA | 4 | 200 | |
| other | constipation | Gastrointestinal disorders | TR-701 FA | 4 | 200 | |
| other | somnolence | Nervous system disorders | TR-701 FA | 4 | 200 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TR-701 FA | ||
| Total, other adverse events | TR-701 FA | 58 | 200 |
| Total, serious adverse events | TR-701 FA | 2 | 200 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27530088 | RESULT |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01519778
GET https://conductscience.org/api/trials/v1/NCT01519778/registered