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NCT01170221 · ClinicalTrials.gov registry record · Phase 3
TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.
A Phase 3 study, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 3
- Development phase
- 667
- Enrollment target
NCT01170221: Completed Phase 3 study, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
NCT01170221 is a Phase 3 study that has completed, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 667 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01170221, a Phase 3 study, has completed, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 667 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 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
Primary Outcome
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
Interventions
- DRUG Linezolid
- DRUG TR-701 FA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 667 participants |
| Start Date | 2010-08-15 |
| Est. Completion | 2011-09-30 |
| Phase | Phase 3 |
Sponsor
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)18 total trials
What the finished NCT01170221 record still lists
NCT01170221 is an interventional study that assigns participants to a tested intervention. The registered 667 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Linezolid is the first listed.
NCT01170221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01170221 about?
NCT01170221 is a clinical study titled "TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.". This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. P...
What is the current status of trial NCT01170221?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 667 participants. The study started on 2010-08-15. Estimated completion is 2011-09-30.
What interventions are being tested in trial NCT01170221?
The interventions under investigation include: Linezolid (DRUG), TR-701 FA (DRUG).
Who is sponsoring clinical trial NCT01170221?
This trial is sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01170221's enrollment target sits among peer trials
667 551st of 2000 higher than 1,450 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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