Conditions: Abscess Wound Infection Surgical Site Infection Cellulitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 698
Healthy volunteers: no

Brief summary:
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

Detailed description:

Arms:
arm 1: Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg. arm 2: Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.

Interventions: intervention 1: Dalbavancin intervention 2: Dalbavancin-matching Placebo
Intervention descriptions: intervention 1: Dalbavancin IV infusion over 30 minutes. intervention 2: Dalbavancin-matching placebo IV infusion over 30 minutes.

Protocol document: