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NCT02066402 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Bacterial Infections, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 598
- Enrollment target
- 20
- Study locations
NCT02066402: Completed Phase 3 study of Bacterial Infections, sponsored by Bayer.
NCT02066402 is a Phase 3 study of Bacterial Infections that has completed, run by Bayer. The registered enrollment target is 598 participants, above the 106-participant average among 17 other Bacterial Infections trials with a reported enrollment target (464% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02066402, a Phase 3 study of Bacterial Infections, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 598 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Linezolid
- DRUG Tedizolid (BAY119-2631)
- DRUG Placebo Tedizolid (BAY119-2631)
- DRUG Placebo Linezolid
Study Locations (20)
Jiangsu
- - Nanjing
- - Nanjing
- - Suzhou
- - Wuxi
California
- - Chula Vista
- - La Mesa
- - Oceanside
Hunan
- - Changsha
- - Changsha
- - Changsha
Guangdong
- - Guangzhou
- - Guangzhou
Liaoning
- - Dalian
- - Shenyang
Nevada
- - Las Vegas
New Jersey
- - Teaneck
Anhui
- - Wuhu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 598 participants |
| Start Date | 2014-03-04 |
| Est. Completion | 2016-04-18 |
| Phase | Phase 3 |
What the finished NCT02066402 record still lists
NCT02066402 is an interventional study that assigns participants to a tested intervention. The registered 598 participants enrollment target is mid-sized for trials with a published cap, above the 106-participant average among 17 other Bacterial Infections trials with a reported enrollment target (464% higher).
The record links to 1 condition, with Bacterial Infections appearing as the primary indexed condition, and to 4 interventions - of which Linezolid is the first listed.
NCT02066402 names 20 study sites across 11 states, led by Jiangsu, California, Hunan.
Frequently Asked Questions
What is clinical trial NCT02066402 about?
NCT02066402 is a clinical study titled "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)". This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind,...
What is the current status of trial NCT02066402?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 598 participants. The study started on 2014-03-04. Estimated completion is 2016-04-18.
What conditions does trial NCT02066402 study?
This clinical trial studies the following conditions: Bacterial Infections.
What interventions are being tested in trial NCT02066402?
The interventions under investigation include: Linezolid (DRUG), Tedizolid (BAY119-2631) (DRUG), Placebo Tedizolid (BAY119-2631) (DRUG), Placebo Linezolid (DRUG).
Who is sponsoring clinical trial NCT02066402?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02066402 being conducted?
This trial has 20 study locations across California, Nevada, New Jersey, Anhui, Fujian. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02066402's enrollment target sits among peer trials
598 2nd of 17 the highest of 17 other Bacterial Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacterial Infections 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.
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