TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Public ClinicalTrials.gov record NCT01421511. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration. Approximately 100 to 140 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment.
Study identification
- NCT ID
- NCT01421511
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Industry
- Enrollment
- 666 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 15, 2011 (Actual)
- Primary completion
- Jan 10, 2013 (Actual)
- Completion
- Jan 10, 2013 (Actual)
- Last update posted
- Aug 29, 2018
2011 – 2013
United States locations
- U.S. sites
- 35
- U.S. states
- 20
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Trius investigator site 159 | Dothan | Alabama | 36305 | — |
| Trius investigator site 103 | Chula Vista | California | 91911 | — |
| Trius investigator site 143 | Escondido | California | 92025 | — |
| Trius investigator site 105 | La Mesa | California | 91942 | — |
| Trius investigator site 106 | Long Beach | California | 90813 | — |
| Trius investigator site 157 | Long Beach | California | 90813 | — |
| Trius investigator site 142 | National City | California | 91950 | — |
| Trius investigator site 170 | San Diego | California | 92123 | — |
| Trius investigator site 167 | Santa Ana | California | 92701 | — |
| Trius investigator site 168 | Stockton | California | 95204 | — |
| Trius investigator site 141 | Sylmar | California | 91342 | — |
| Trius investigator site 139 | Denver | Colorado | 80218 | — |
| Trius investigator site 137 | Newark | Delaware | 19718 | — |
| Trius investigator site 166 | Edgewater | Florida | 32132 | — |
| Trius investigator site 101 | Columbus | Georgia | 31904 | — |
| Trius investigator site 138 | Carmel | Indiana | 46032 | — |
| Trius investigator site 144 | Owensboro | Kentucky | 42303 | — |
| Trius investigator site 150 | Baton Rouge | Louisiana | 70809 | — |
| Trius investigator site 165 | Eunice | Louisiana | 70535 | — |
| Trius investigator site 154 | Boston | Massachusetts | 02115 | — |
| Trius investigator site 146 | Springfield | Massachusetts | 01199 | — |
| Trius investigator site 136 | West Roxbury | Massachusetts | 02132 | — |
| Trius investigator site 163 | Royal Oak | Michigan | 48073 | — |
| Trius investigator site 153 | Minneapolis | Minnesota | 55415 | — |
| Trius investigator site 149 | Picayune | Mississippi | 39466 | — |
| Trius investigator site 164 | Creve Coeur | Missouri | 63141 | — |
| Trius investigator site 160 | Las Vegas | Nevada | 89169 | — |
| Trius investigator site 147 | Teaneck | New Jersey | 07666 | — |
| Trius investigator site 140 | Columbus | Ohio | 43215 | — |
| Trius investigator site 162 | Lima | Ohio | 45801 | — |
| Trius investigator site 161 | Rapid City | South Dakota | 57702 | — |
| Trius investigator site 155 | Franklin | Tennessee | 37064 | — |
| Trius investigator site 145 | Memphis | Tennessee | 38104 | — |
| Trius investigator site 169 | Smyrna | Tennessee | 37167 | — |
| Trius investigator site 148 | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 82 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01421511, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 29, 2018 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01421511 live on ClinicalTrials.gov.