A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections
Overview
- Phase
- Phase 3
- Intervention
- ceftobiprole medocaril
- Conditions
- Acute Bacterial Skin and Skin Structure Infections
- Sponsor
- Basilea Pharmaceutica
- Enrollment
- 679
- Locations
- 32
- Primary Endpoint
- Early Clinical Response
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
Detailed Description
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients with ABSSSIs. Randomization was stratified by study site and type of ABSSSI (with major cutaneous abscess comprising ≤ 30% of the Intent-to-Treat \[ITT\] population). Primary endpoint for FDA: Early clinical response based on the percent reduction in lesion size at 48-72 hours compared to baseline in patients who did not receive rescue therapy and were alive, in the ITT population. Primary endpoint for EMA: Investigator-assessed clinical success at the test-of-cure (TOC) visit 15-22 days after randomization, in the co-primary ITT and Clinically Evaluable (CE) populations.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ceftobiprole medocaril
Patients treated with ceftobiprole medocaril 500 mg q8h (with dose adjustment for renal impairment).
Intervention: ceftobiprole medocaril
vancomycin+aztreonam
Patients treated with vancomycin 1000 mg (or 15 mg/kg) q12h plus aztreonam 1000 mg q12h (both with dose adjustment for renal impairment).
Intervention: vancomycin+aztreonam
Outcomes
Primary Outcomes
Early Clinical Response
Time Frame: 48-72 hours after start of study drug treatment
Comparison of early clinical response, including ≥ 20% reduction from baseline in the primary lesion area (based on ruler measurements), survival for ≥ 72 hours and no rescue therapy in the ITT population
Secondary Outcomes
- Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population(15-22 days after randomization)
- Investigator-assessed Clinical Success in the ITT Population(15-22 days after randomization)