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NCT02570490 · ClinicalTrials.gov registry record · Phase 3
Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Phase 3 study of Acute Bacterial Skin and Skin Structure Infections, sponsored by Arrevus.
- Completed
- Registry status
- Phase 3
- Development phase
- 716
- Enrollment target
- 20
- Study locations
NCT02570490: Completed Phase 3 study of Acute Bacterial Skin and Skin Structure Infections, sponsored by Arrevus.
NCT02570490 is a Phase 3 study of Acute Bacterial Skin and Skin Structure Infections that has completed, run by Arrevus. The registered enrollment target is 716 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02570490, a Phase 3 study of Acute Bacterial Skin and Skin Structure Infections, has completed, sponsored by Arrevus.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 716 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI
Primary Outcome
Proportion of subjects with a response for Early Clinical Response (ECR), defined as alive and achieved ≥ 20% reduction from baseline in the lesion size at 48-72 hours after start of study drug, without receipt of additional non-study antibiotic therapy.
Conditions Studied
Interventions
- DRUG linezolid
- DRUG sodium fusidate
Study Locations (20)
California
- - Anaheim
- - Bakersfield
- - Buena Park
- - Fountain Valley
- - La Mesa
- - La Palma
- - Long Beach
- - Los Angeles
- - Modesto
- - National City
- - Oceanside
- - Riverside
- - San Diego
- - San Diego
- - San Diego
- - San Diego
- - San Diego
- - San Dimas
- - Stockton
- - Sylmar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 716 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT02570490 record still lists
NCT02570490 is an interventional study that assigns participants to a tested intervention. The registered 716 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 1 condition, with Acute Bacterial Skin and Skin Structure Infections appearing as the primary indexed condition, and to 2 interventions - of which linezolid is the first listed.
NCT02570490 names 20 study sites across 1 states, led by California.
Frequently Asked Questions
What is clinical trial NCT02570490 about?
NCT02570490 is a clinical study titled "Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections". Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI
What is the current status of trial NCT02570490?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 716 participants. The study started on 2015-11. Estimated completion is 2016-11.
What conditions does trial NCT02570490 study?
This clinical trial studies the following conditions: Acute Bacterial Skin and Skin Structure Infections.
What interventions are being tested in trial NCT02570490?
The interventions under investigation include: linezolid (DRUG), sodium fusidate (DRUG).
Who is sponsoring clinical trial NCT02570490?
This trial is sponsored by Arrevus, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02570490 being conducted?
This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Bacterial Skin and Skin Structure Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02570490's enrollment target sits among peer trials
716 498th of 2000 higher than 1,503 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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