Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

Completed · Phase 3

Conditions studied: Staphylococcus Aureus Bacteremia

In brief

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).

Key facts

Study ID

NCT03138733

Run by

Basilea Pharmaceutica

People needed

390

Starts

2018-08-26

Expected to finish

2022-03-11

Last updated by the study team

2023-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 < 4,000 cells/µL, 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

You may not qualify if…

• 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

Where it is running

• 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
• Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven, Anesthesiology and Intensive Care Department — Sliven, Bulgaria
• University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery — Sofia, Bulgaria
• De La Costa Clinic Ltd. — Barranquilla, Colombia
• JSC Rustavi Central Hospital — Rustavi, Georgia
• LTD High Technology Medical Center University Clinic — Tbilisi, Georgia
• LTD Academician G. Chapidze Emergency Cardiology Center — Tbilisi, Georgia
• LTD Institute of Clinical Cardiology — Tbilisi, Georgia
• LTD Academician Vakhtang Bochorishvili Clinic — Tbilisi, Georgia
• LTD Central University Clinic After Academic N. Kipshidze — Tbilisi, Georgia
• LTD N 5 Clinikal Hospital — Tbilisi, Georgia
• University Hospital Regensburg, Department of Infectious Diseases — Regensburg, Germany
• "LAIKO" General Hospital, 1st Department of Internal Medicine — Athens, Greece
• Bnai Zion Medical Center — Haifa, Israel
• The Baruch Padeh Medical Center — Poria Illit, Israel
• Chaim Sheba Medical Center — Ramat Gan, Israel
• eStudy Site - Chula Vista - PPDS — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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