Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections
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|ClinicalTrials.gov Identifier: NCT03137173|
Recruitment Status : Completed
First Posted : May 2, 2017
Results First Posted : May 18, 2020
Last Update Posted : October 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Bacterial Skin and Skin Structure Infections||Drug: ceftobiprole medocaril Drug: vancomycin+aztreonam||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||679 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||February 19, 2018|
|Actual Primary Completion Date :||April 22, 2019|
|Actual Study Completion Date :||April 22, 2019|
Experimental: ceftobiprole medocaril
Patients treated with ceftobiprole medocaril 500 mg q8h (with dose adjustment for renal impairment).
Drug: ceftobiprole medocaril
ceftobiprole 500 mg was to be administered every 8 hours as a 2-hour IV infusion (with dose adjustment for renal impairment). The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.
Other Name: ceftobiprole
Active Comparator: 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).
Vancomycin 1000 mg (or 15 mg/kg) was to be administered every 12 hours (with dose adjustment for renal impairment) as 2-hour IV infusion. Vancomycin dose adjustment for morbidly obese and hypermetabolic patients was to be done according to local standard of care. When locally available, vancomycin trough testing (VTT) might have been used by the unblinded pharmacist or delegate to adjust the vancomycin dose. The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.
Aztreonam 1000 mg was to be administered as a 0.5-hour IV infusion every 12 hours. If CLCR was < 30 mL/min (i.e., severe renal impairment), the aztreonam dosage regimen was to be adjusted. The requirement to continue aztreonam therapy beyond Day 3 was to be reassessed at the 72-hour study visit.
- 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
- Investigator-assessed Clinical Success in the ITT Population [ Time Frame: 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
- Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137173
|Study Director:||Kamal Hamed, MD, MPH||Basilea Pharmaceutica|