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COMPLETED
NCT03138733
PHASE3

Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

Sponsor: Basilea Pharmaceutica

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

390

Start Date

2018-08-26

Completion Date

2022-03-11

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

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

Locations (60)

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

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

Sieff Medical Center

Safed, Israel

Sourasky Medical Center

Tel Aviv, Israel

IRCCS-University Hospital San Martino-IST, Infectious Diseases Division

Genoa, Italy

University of Milan-Bicocca- S.Gerardo Hospital

Monza, Italy

Giuliano Isontina University Health Authority

Trieste, Italy

Central Friuli University Healthcare Company

Udine, Italy

Fray Antonio Alcalde Guadalajara Civil Hospital

Guadalajara, Mexico

Dr. Jose Eleuterio Gonzalez Monterrey University Hospital

Monterrey, Mexico

INDICASAT SMO / Santo Tomas Hospital, Investigation Department

Panama City, Panama

St. Joseph Belgorod Regional Clinical Hospital

Belgorod, Russia

Vinogradov Moscow Municipal Hospital, Department of Surgery #14

Moscow, Russia

N.I. Pirogov City Clinical Hospital #1

Moscow, Russia

Federal State Budget Institution "Central Clinical Hospital with Polyclinic" under the Presidential Executive Office of Russian Federation

Moscow, Russia

L.A. Vorokhobov City Clinical Hospital #67

Moscow, Russia

City Hospital #33

Nizhny Novgorod, Russia

Pyatigorsk City Clinical Hospital

Pyatigorsk, Russia

Regional Clinical Hospital

Yaroslavl, Russia

Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Nephrology and Metabolic Disorders with Dialysis "Prof. dr Vasilije Jovanovic"

Belgrade, Serbia

Clinical Center Kragujevac, Center for Anesthesia and Reanimation

Kragujevac, Serbia

Worthwhile Clinical Trials, Lakeview Hospital

Benoni, South Africa

Mediclinic Victoria - Practice of R Moodley and MI Sarwan

Tongaat, South Africa

Hospital del Mar, Department of Intensive Care

Barcelona, Spain

University Hospital de Elche, Infectious Diseases Unit

Elche, Spain

General University Hospital Gregorio Maranon, Infectious Diseases / Internal Medicine

Madrid, Spain

University Hospital Ramon y Cajal, Department of Infectious Diseases

Madrid, Spain

University Hospital Mutua de Terrassa, Unit of Infectious Diseases

Terrassa, Spain

Istanbul Kartal Kosuyolu Yuksek Ihtisas Training and Research Hospital

Istanbul, Turkey (Türkiye)

Ondokuz Mayis University School of Medicine, Department of Infectious Diseases

Samsun, Turkey (Türkiye)

Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital

Dnipro, Ukraine

Dnipropetrovsk City Multispecialty Clinical Hospital #4

Dnipro, Ukraine

Ivano-Frankivsk Regional Clinical Hospital

Ivano-Frankivsk, Ukraine

V.T. Zaitsev Institute of General and Emergency Surgery

Kharkiv, Ukraine

Public Non-Profit Enterprise: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council

Kharkiv, Ukraine

Communal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital named after N.I. Pirogov Vinnytsia Regional Council"

Vinnytsia, Ukraine

City Clinical Hospital #3

Zaporizhzhya, Ukraine