NCT03138733

Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

A Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole Medocaril Compared to Daptomycin in the Treatment of Staphylococcus Aureus Bacteremia, Including Infective Endocarditis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB).

Detailed description

Patients were randomized 1:1 to ceftobiprole or the comparator regimen. Randomization was stratified by study site, dialysis status, and prior antibacterial treatment use within 7 days before randomization. The three phases of the study were: 1. Screening assessments of up to 72 hours prior to randomization 2. Randomization and subsequent active treatment with intravenous (i.v.) study drug (ceftobiprole or daptomycin ± aztreonam). 3. Post-treatment, comprising an end of trial (EOT) visit (within 72 hours of last study-drug administration), Day 35 (± 3 days), Day 42 (± 3 days), and a post-treatment evaluation (PTE) visit on Day 70 (± 5 days) post-randomization.

Conditions

• Staphylococcus Aureus Bacteremia

Interventions

Type	Name	Description
DRUG	Ceftobiprole medocaril	Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion
DRUG	Daptomycin	Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam

Timeline

• Start date: 2018-08-26
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2017-05-03
• Last updated: 2023-11-08
• Results posted: 2023-05-06

Locations

60 sites across 17 countries: United States, Argentina, Bulgaria, Colombia, Georgia, Germany, Greece, Israel, Italy, Mexico, Panama, Russia, Serbia, South Africa, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study