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Omadacycline vs Linezolid in cSSSI
NCT00876850Phase 3
Key facts
- Status
- Withdrawn
- Start
- Jul 2009
- Primary completion
- Jul 2010
- Sponsor
- Paratek Pharmaceuticals
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules
- Drugs
- omadacycline
- Conditions
- Skin and Skin Structure Infection (SSSI)
01
Overview
Phase 3, randomised, single-blind trial of omadacycline in Skin and Skin Structure Infection (SSSI) (2 arms), sponsored by Paratek Pharmaceuticals. Primary endpoint: Clinical success at follow-up at 4 weeks. Planned start Jul 2009; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Omadacycline
Omadacycline 100mg IV / 150mg Oral
Linezolid
Linezolid 600mg IV/Oral (+ Moxifloxacin for gram-negative coverage)
03
Who it enrols
Adult patients with acute complicated skin and skin structure infection requiring at least 4 days of antibiotic therapy.
04
Endpoints
Primary
Clinical success at follow-up
Secondary
Safety of dosing regimens
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