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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
390
Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion
Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam
Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit
Comparison of overall success rates in the mITT population Overall success at PTE for the mITT population was defined as all of the following criteria being met (Responder): 1. Patient alive at Day 70 (± 5 days) post-randomization. 2. No new metastatic foci or complications of the SAB infection. 3. Resolution or improvement of SAB-related clinical signs and symptoms. 4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)
Time frame: PTE visit on Day 70 (± 5 days) post-randomization
Number of Patients With or Without Overall Success at the PTE Visit in the CE Population
Comparison of overall success rates in the Clinical Evaluable (CE) population Overall success at PTE for the CE population was defined as all of the following criteria being met (Responder): 1. Patient alive at Day 70 (± 5 days) post-randomization. 2. No new metastatic foci or complications of the SAB infection. 3. Resolution or improvement of SAB-related clinical signs and symptoms. 4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)
Time frame: At PTE visit on Day 70 (± 5 days) post-randomization
Number of Patients With Microbiological Eradication at the PTE Visit
Comparison of microbiological eradication rates in the mITT population. Microbiological eradication rate was defined as a negative blood culture for S. aureus during study treatment and another negative blood culture during the follow up period up to PTE.
Time frame: At PTE visit on Day 70 (± 5 days) post-randomization
All-cause Mortality at the PTE Visit
Comparison of all-cause mortality rates in the mITT population
Time frame: At PTE visit on Day 70 (± 5 days) post-randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
eStudy Site - Chula Vista - PPDS
Chula Vista, California, United States
Triple O Medical Services Inc
West Palm Beach, Florida, United States
Mercury Street Medical Group
Butte, Montana, United States
eStudy Site - Las Vegas - PPDS
Las Vegas, Nevada, United States
Remington Davis Inc.
Columbus, Ohio, United States
Central Hospital de San Isidro Melchor Posse
Buenos Aires, Argentina
Medical Institute Platense SA
La Plata, Argentina
British Sanatorium SA
Rosario, Argentina
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Intensive Care Clinic
Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of General, Purulent-Septic, Pediatric and One Day Surgery
Rousse, Bulgaria
...and 50 more locations
Number of Patients With or Without New Metastatic Foci or Other Complications of SAB Developed After Day 7
Comparison of complication rates in the mITT population defined by number of patients with development of new metastatic foci or other complications of SAB after Day 7
Time frame: Assessment after Day 7 post-randomization through to post-treatment evaluation (PTE) visit on Day 70 (± 5 days)
Time to Staphylococcus Aureus Bloodstream Clearance
Time-to-event in the mITT Bloodstream clearance was defined as two consecutive study days with blood-culture-negative assessments for S. aureus, without any subsequent S. aureus relapse or reinfection
Time frame: Up to 6 weeks post-randomization
Number of Patients With or Without Adverse Events (AEs)
Treatment-emergent adverse events in the safety population
Time frame: AEs were assessed from the first dose of study drug through the post-treatment evaluation (PTE) visit on Day 70 (± 5 days)