Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
- Conditions
- Acute Bacterial Skin and Skin Structure Infections
- Interventions
- Drug: vancomycin+aztreonam
- Registration Number
- NCT03137173
- Lead Sponsor
- Basilea Pharmaceutica
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 679
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (32)
Physician Alliance Research Center
🇺🇸Anaheim, California, United States
Central Valley Research LLC
🇺🇸Fresno, California, United States
L&C Professional Medical Research Institute
🇺🇸Miami, Florida, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
Gonzalez MD and Aswad MD Health Services
🇺🇸Coral Gables, Florida, United States
"University Multiprofile Hospital for Active Treatment and Emergency Medicine ""N. I. Pirogov"", Clinic of Purulent-Septic Surgery-"N.I. Pirogov""
🇧🇬Sofia, Bulgaria
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
University of SzegednAlbert Szent-Gyorgyi Clinical Center
🇭🇺Szeged, Hungary
Kaposi Mor Teaching Hospital
🇭🇺Kaposvar, Hungary
CRU Hungary Ltd.
🇭🇺Miskolc, Hungary
Csolnoky Ferenc Hospital
🇭🇺Veszprem, Hungary
Dnipropetrovsk I.I. Mechnуkov Regional Clinical Hospital, Surgery Department #2
🇺🇦Dnipro, Ukraine
Lviv Regional Clinical Hospital
🇺🇦Lviv, Ukraine
Ivano-Frankivsk City Clinical Hospital Surgery 1
🇺🇦Ivano-Frankivsk, Ukraine
Ivano-Frankivsk City Clinical Hospital General Surgery
🇺🇦Ivano-Frankivsk, Ukraine
Kyiv City Clinical Hospital
🇺🇦Kyiv, Ukraine
Public City Clinical Hospital of Emergency Medical Care
🇺🇦Lviv, Ukraine
eStudySite - Las Vegas - PPDS
🇺🇸Las Vegas, Nevada, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Omnibus Clinical Research
🇺🇸La Palma, California, United States
Saint Joseph's Clinical Research
🇺🇸Anaheim, California, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
eStudySite - Chula Vista - PPDS
🇺🇸Chula Vista, California, United States
eStudySite - La Mesa - PPDS
🇺🇸La Mesa, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Central Valley Research, LLC
🇺🇸Modesto, California, United States
University Multiprofile Hospital for Active Treatment
🇧🇬Ruse, Bulgaria
Central City Clinical Hospital
🇺🇦Uzhhorod, Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
🇺🇦Vinnytsia, Ukraine
Central District Hospital
🇺🇦Zhytomyr, Ukraine
Zaporizhia City Clinical Hospital of Urgent and Emergency Medical Care
🇺🇦Zaporizhia, Ukraine
Alliance Research LLC
🇺🇸Long Beach, California, United States