Phase 3
N=390
Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia
Bottom Line
View on ClinicalTrials.gov: NCT03138733 ↗Enrolled (actual)
390
Serious AEs
20.8%
Results posted
May 2023
Primary outcome: Primary: Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit — 132; 136; 57; 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ceftobiprole medocaril (Drug); Daptomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Basilea Pharmaceutica
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit |
132; 136; 57; 62 | — |
| SECONDARY Number of Patients With or Without Overall Success at the PTE Visit in the CE Population |
127; 130; 36; 37 | — |
| SECONDARY Number of Patients With Microbiological Eradication at the PTE Visit |
155; 153 | — |
| SECONDARY All-cause Mortality at the PTE Visit |
17; 18; 172; 180 | — |
| SECONDARY Number of Patients With or Without New Metastatic Foci or Other Complications of SAB Developed After Day 7 |
11; 11; 178; 187 | — |
| SECONDARY Time to Staphylococcus Aureus Bloodstream Clearance |
4; 4 | — |
| SECONDARY Number of Patients With or Without Adverse Events (AEs) |
121; 117; 25; 11; 29; 38 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 years of age
- Staphylococcus aureus bacteremia (SAB), based on at least one positive blood culture obtained within the 72 h prior to randomization
- At least one of the following signs or symptoms of bacteremia:
- fever (e.g.≥ 38 °C/100.4 °F measured orally)
- white blood cell count > 10, 000 or 10% immature neutrophils (bands)
- tachycardia (heart rate > 90 bpm)
- hypotension (systolic blood pressure < 90 mmHg)
- At least one of the following:
- SAB in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis
- Persistent SAB
- Definite native-valve right-sided infective endocarditis by Modified Duke's Criteria
- Other forms of complicated SAB
- Osteomyelitis (including vertebral, sternal, or long-bone osteomyelitis)
- Epidural or cerebral abscess
- Other inclusion criteria have been applied
Exclusion Criteria
- Treatment with potentially effective (anti-staphylococcal) systemic antibacterial treatment for more than 48 h within the 7 days prior to randomization; Exception: Documented failure of bloodstream clearance
- Bloodstream or non-bloodstream concomitant infections with Gram-negative bacteria that are known to be non-susceptible to either ceftobiprole or aztreonam
- Left-sided infective endocarditis
- Prosthetic cardiac valves or valve support rings, cardiac pacemakers, automatic implantable cardioverter-defibrillator, or left-ventricular assist devices
- Community- or hospital-acquired pneumonia
- Opportunistic infections within 30 days prior to randomization, where the underlying cause of these infections is still active
- Requirement for continuous renal-replacement therapy
- Women who are pregnant or nursing
- Other exclusion criteria have been applied
Data sourced from ClinicalTrials.gov (NCT03138733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.