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Dalbavancin vs Vancomycin/Linezolid in ABSSSI (DISCOVER-2)
NCT01431339Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2011
- Primary completion
- Nov 2012
- Countries
- 14
- Sponsor
- Allergan
- Modality
- Peptides, Small Molecules
- Drugs
- dalbavancin
- Conditions
- acute bacterial skin and skin structure infection (ABSSSI)
01
Overview
Phase 3, randomised, double-blind trial of dalbavancin in acute bacterial skin and skin structure infection (ABSSSI) (2 arms), sponsored by Allergan. Primary endpoint: Early Clinical Efficacy. Started Jul 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dalbavancin
IV Dalbavancin 1000 mg Day 1, 500 mg Day 8
Vancomycin/Linezolid
IV Vancomycin q12h (min 3 days) -> Oral Linezolid q12h (total 10-14 days)
03
Who it enrols
Adult patients with suspected or confirmed Gram-positive ABSSSI requiring IV therapy, excluding those with resistant organisms, osteomyelitis, or diabetic foot ulcers.
04
Endpoints
Primary
Early Clinical Efficacy
Secondary
Clinical Status at End of Treatment
>= 20% Reduction in Lesion Area
Clinical Status at Follow-Up Visit
05
Results
Primary endpoints met
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