Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
vancomycin+aztreonam	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).
ceftobiprole medocaril	ceftobiprole medocaril	Patients treated with ceftobiprole medocaril 500 mg q8h (with dose adjustment for renal impairment).

Primary Outcome Measures

Name	Time	Method
Early Clinical Response	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 Outcome Measures

Name	Time	Method
Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population	15-22 days after randomization	Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the clinically evaluable (CE) population
Investigator-assessed Clinical Success in the ITT Population	15-22 days after randomization	Comparison of investigator-assessed clinical success (based on resolution of baseline signs and symptoms of the primary infection) in the ITT population

Locations (32): Physician Alliance Research Center
🇺🇸
Anaheim, California, United States
Saint Joseph's Clinical Research
🇺🇸
Anaheim, California, United States
eStudySite - Chula Vista - PPDS
🇺🇸
Chula Vista, California, United States
Central Valley Research LLC
🇺🇸
Fresno, California, United States
Marvel Clinical Research
🇺🇸
Huntington Beach, California, United States
eStudySite - La Mesa - PPDS
🇺🇸
La Mesa, California, United States
Omnibus Clinical Research
🇺🇸
La Palma, California, United States
Alliance Research LLC
🇺🇸
Long Beach, California, United States
Long Beach Clinical Trials
🇺🇸
Long Beach, California, United States
Central Valley Research, LLC
🇺🇸
Modesto, California, United States
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Physician Alliance Research Center
🇺🇸Anaheim, California, United States