Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
NCT ID: NCT03138733
Last Updated: 2023-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2018-08-26
2022-03-11
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ceftobiprole medocaril
Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)
Ceftobiprole medocaril
Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion
Daptomycin
Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards), with or without aztreonam
Daptomycin
Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam
Interventions
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Ceftobiprole medocaril
Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion
Daptomycin
Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam
Eligibility Criteria
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Inclusion Criteria
* 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:
1. fever (e.g.≥ 38 °C/100.4 °F measured orally)
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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
Basilea Pharmaceutica
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Engelhardt, MD
Role: STUDY_DIRECTOR
Basilea Pharmaceutica
Locations
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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
Countries
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References
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Hamed K, Engelhardt M, Jones ME, Saulay M, Holland TL, Seifert H, Fowler VG Jr. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiol. 2020 Jan;15(1):35-48. doi: 10.2217/fmb-2019-0332. Epub 2020 Jan 10.
Holland TL, Cosgrove SE, Doernberg SB, Jenkins TC, Turner NA, Boucher HW, Pavlov O, Titov I, Kosulnykov S, Atanasov B, Poromanski I, Makhviladze M, Anderzhanova A, Stryjewski ME, Assadi Gehr M, Engelhardt M, Hamed K, Ionescu D, Jones M, Saulay M, Smart J, Seifert H, Fowler VG Jr; ERADICATE Study Group. Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. doi: 10.1056/NEJMoa2300220. Epub 2023 Sep 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BPR-CS-009
Identifier Type: -
Identifier Source: org_study_id
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