Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basilea Pharmaceutica
• Collaborator: Department of Health and Human Services
• Treatments: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins; Daptomycin

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 two of the following signs or symptoms of bacteremia:

1. fever ≥ 38°C/100.4°F

2. white blood cell count > 10,000 or < 4,000 cells/µL, or > 10% immature neutrophils (bands)

3. tachycardia (heart rate > 90 bpm)

4. hypotension (systolic blood pressure < 90 mmHg)

• At least one of the following:

1. SAB in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis

2. Persistent SAB

3. Definite native-valve right-sided infective endocarditis by Modified Duke's Criteria

4. Other forms of complicated SAB

5. Osteomyelitis (including vertebral, sternal, or long-bone osteomyelitis)

6. Epidural or cerebral abscess

• Other inclusion criteria may apply

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 may apply