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Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

Primary Purpose

Staphylococcus Aureus Bacteremia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ceftobiprole medocaril
Daptomycin
Sponsored by
Basilea Pharmaceutica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcus Aureus Bacteremia focused on measuring Ceftobiprole, daptomycin, Staphylococcus aureus, Bacteremia, bloodstream infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • eStudy Site - Chula Vista - PPDS
  • Triple O Medical Services Inc
  • Mercury Street Medical Group
  • eStudy Site - Las Vegas - PPDS
  • Remington Davis Inc.
  • Central Hospital de San Isidro Melchor Posse
  • Medical Institute Platense SA
  • British Sanatorium SA
  • University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Intensive Care Clinic
  • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of General, Purulent-Septic, Pediatric and One Day Surgery
  • Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven, Anesthesiology and Intensive Care Department
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery
  • De La Costa Clinic Ltd.
  • JSC Rustavi Central Hospital
  • LTD High Technology Medical Center University Clinic
  • LTD Academician G. Chapidze Emergency Cardiology Center
  • LTD Institute of Clinical Cardiology
  • LTD Academician Vakhtang Bochorishvili Clinic
  • LTD Central University Clinic After Academic N. Kipshidze
  • LTD N 5 Clinikal Hospital
  • University Hospital Regensburg, Department of Infectious Diseases
  • "LAIKO" General Hospital, 1st Department of Internal Medicine
  • Bnai Zion Medical Center
  • The Baruch Padeh Medical Center
  • Chaim Sheba Medical Center
  • Sieff Medical Center
  • Sourasky Medical Center
  • IRCCS-University Hospital San Martino-IST, Infectious Diseases Division
  • University of Milan-Bicocca- S.Gerardo Hospital
  • Giuliano Isontina University Health Authority
  • Central Friuli University Healthcare Company
  • Fray Antonio Alcalde Guadalajara Civil Hospital
  • Dr. Jose Eleuterio Gonzalez Monterrey University Hospital
  • INDICASAT SMO / Santo Tomas Hospital, Investigation Department
  • St. Joseph Belgorod Regional Clinical Hospital
  • Vinogradov Moscow Municipal Hospital, Department of Surgery #14
  • N.I. Pirogov City Clinical Hospital #1
  • Federal State Budget Institution "Central Clinical Hospital with Polyclinic" under the Presidential Executive Office of Russian Federation
  • L.A. Vorokhobov City Clinical Hospital #67
  • City Hospital #33
  • Pyatigorsk City Clinical Hospital
  • Regional Clinical Hospital
  • Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Nephrology and Metabolic Disorders with Dialysis "Prof. dr Vasilije Jovanovic"
  • Clinical Center Kragujevac, Center for Anesthesia and Reanimation
  • Worthwhile Clinical Trials, Lakeview Hospital
  • Mediclinic Victoria - Practice of R Moodley and MI Sarwan
  • Hospital del Mar, Department of Intensive Care
  • University Hospital de Elche, Infectious Diseases Unit
  • General University Hospital Gregorio Maranon, Infectious Diseases / Internal Medicine
  • University Hospital Ramon y Cajal, Department of Infectious Diseases
  • University Hospital Mutua de Terrassa, Unit of Infectious Diseases
  • Istanbul Kartal Kosuyolu Yuksek Ihtisas Training and Research Hospital
  • Ondokuz Mayis University School of Medicine, Department of Infectious Diseases
  • Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
  • Dnipropetrovsk City Multispecialty Clinical Hospital #4
  • Ivano-Frankivsk Regional Clinical Hospital
  • V.T. Zaitsev Institute of General and Emergency Surgery
  • Public Non-Profit Enterprise: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council
  • Communal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital named after N.I. Pirogov Vinnytsia Regional Council"
  • City Clinical Hospital #3

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftobiprole medocaril

Daptomycin

Arm Description

Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)

Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards), with or without aztreonam

Outcomes

Primary Outcome Measures

Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit
Comparison of overall success rates in the mITT population Overall success at PTE for the mITT population was defined as all of the following criteria being met (Responder): Patient alive at Day 70 (± 5 days) post-randomization. No new metastatic foci or complications of the SAB infection. Resolution or improvement of SAB-related clinical signs and symptoms. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)

Secondary Outcome Measures

Number of Patients With or Without Overall Success at the PTE Visit in the CE Population
Comparison of overall success rates in the Clinical Evaluable (CE) population Overall success at PTE for the CE population was defined as all of the following criteria being met (Responder): Patient alive at Day 70 (± 5 days) post-randomization. No new metastatic foci or complications of the SAB infection. Resolution or improvement of SAB-related clinical signs and symptoms. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)
Number of Patients With Microbiological Eradication at the PTE Visit
Comparison of microbiological eradication rates in the mITT population. Microbiological eradication rate was defined as a negative blood culture for S. aureus during study treatment and another negative blood culture during the follow up period up to PTE.
All-cause Mortality at the PTE Visit
Comparison of all-cause mortality rates in the mITT population
Number of Patients With or Without New Metastatic Foci or Other Complications of SAB Developed After Day 7
Comparison of complication rates in the mITT population defined by number of patients with development of new metastatic foci or other complications of SAB after Day 7
Time to Staphylococcus Aureus Bloodstream Clearance
Time-to-event in the mITT Bloodstream clearance was defined as two consecutive study days with blood-culture-negative assessments for S. aureus, without any subsequent S. aureus relapse or reinfection
Number of Patients With or Without Adverse Events (AEs)
Treatment-emergent adverse events in the safety population

Full Information

First Posted
April 27, 2017
Last Updated
May 9, 2023
Sponsor
Basilea Pharmaceutica
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT03138733
Brief Title
Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2018 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Basilea Pharmaceutica
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed Description
Patients were randomized 1:1 to ceftobiprole or the comparator regimen. Randomization was stratified by study site, dialysis status, and prior antibacterial treatment use within 7 days before randomization. The three phases of the study were: Screening assessments of up to 72 hours prior to randomization Randomization and subsequent active treatment with intravenous (i.v.) study drug (ceftobiprole or daptomycin ± aztreonam). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus Bacteremia
Keywords
Ceftobiprole, daptomycin, Staphylococcus aureus, Bacteremia, bloodstream infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftobiprole medocaril
Arm Type
Experimental
Arm Description
Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)
Arm Title
Daptomycin
Arm Type
Active Comparator
Arm Description
Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards), with or without aztreonam
Intervention Type
Drug
Intervention Name(s)
Ceftobiprole medocaril
Intervention Description
Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Intervention Description
Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam
Primary Outcome Measure Information:
Title
Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit
Description
Comparison of overall success rates in the mITT population Overall success at PTE for the mITT population was defined as all of the following criteria being met (Responder): Patient alive at Day 70 (± 5 days) post-randomization. No new metastatic foci or complications of the SAB infection. Resolution or improvement of SAB-related clinical signs and symptoms. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)
Time Frame
PTE visit on Day 70 (± 5 days) post-randomization
Secondary Outcome Measure Information:
Title
Number of Patients With or Without Overall Success at the PTE Visit in the CE Population
Description
Comparison of overall success rates in the Clinical Evaluable (CE) population Overall success at PTE for the CE population was defined as all of the following criteria being met (Responder): Patient alive at Day 70 (± 5 days) post-randomization. No new metastatic foci or complications of the SAB infection. Resolution or improvement of SAB-related clinical signs and symptoms. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)
Time Frame
At PTE visit on Day 70 (± 5 days) post-randomization
Title
Number of Patients With Microbiological Eradication at the PTE Visit
Description
Comparison of microbiological eradication rates in the mITT population. Microbiological eradication rate was defined as a negative blood culture for S. aureus during study treatment and another negative blood culture during the follow up period up to PTE.
Time Frame
At PTE visit on Day 70 (± 5 days) post-randomization
Title
All-cause Mortality at the PTE Visit
Description
Comparison of all-cause mortality rates in the mITT population
Time Frame
At PTE visit on Day 70 (± 5 days) post-randomization
Title
Number of Patients With or Without New Metastatic Foci or Other Complications of SAB Developed After Day 7
Description
Comparison of complication rates in the mITT population defined by number of patients with development of new metastatic foci or other complications of SAB after Day 7
Time Frame
Assessment after Day 7 post-randomization through to post-treatment evaluation (PTE) visit on Day 70 (± 5 days)
Title
Time to Staphylococcus Aureus Bloodstream Clearance
Description
Time-to-event in the mITT Bloodstream clearance was defined as two consecutive study days with blood-culture-negative assessments for S. aureus, without any subsequent S. aureus relapse or reinfection
Time Frame
Up to 6 weeks post-randomization
Title
Number of Patients With or Without Adverse Events (AEs)
Description
Treatment-emergent adverse events in the safety population
Time Frame
AEs were assessed from the first dose of study drug through the post-treatment evaluation (PTE) visit on Day 70 (± 5 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Engelhardt, MD
Organizational Affiliation
Basilea Pharmaceutica
Official's Role
Study Director
Facility Information:
Facility Name
eStudy Site - Chula Vista - PPDS
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Triple O Medical Services Inc
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
eStudy Site - Las Vegas - PPDS
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Remington Davis Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Central Hospital de San Isidro Melchor Posse
City
Buenos Aires
ZIP/Postal Code
81641
Country
Argentina
Facility Name
Medical Institute Platense SA
City
La Plata
ZIP/Postal Code
B1900AVG
Country
Argentina
Facility Name
British Sanatorium SA
City
Rosario
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Intensive Care Clinic
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of General, Purulent-Septic, Pediatric and One Day Surgery
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven, Anesthesiology and Intensive Care Department
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
De La Costa Clinic Ltd.
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Facility Name
JSC Rustavi Central Hospital
City
Rustavi
ZIP/Postal Code
3700
Country
Georgia
Facility Name
LTD High Technology Medical Center University Clinic
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
LTD Academician G. Chapidze Emergency Cardiology Center
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD Institute of Clinical Cardiology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD Academician Vakhtang Bochorishvili Clinic
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Central University Clinic After Academic N. Kipshidze
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD N 5 Clinikal Hospital
City
Tbilisi
ZIP/Postal Code
0191
Country
Georgia
Facility Name
University Hospital Regensburg, Department of Infectious Diseases
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
"LAIKO" General Hospital, 1st Department of Internal Medicine
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
The Baruch Padeh Medical Center
City
Poriyya 'Illit
ZIP/Postal Code
1520800
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Sieff Medical Center
City
Safed
ZIP/Postal Code
1311001
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
IRCCS-University Hospital San Martino-IST, Infectious Diseases Division
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
University of Milan-Bicocca- S.Gerardo Hospital
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Giuliano Isontina University Health Authority
City
Trieste
ZIP/Postal Code
34125
Country
Italy
Facility Name
Central Friuli University Healthcare Company
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Fray Antonio Alcalde Guadalajara Civil Hospital
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Dr. Jose Eleuterio Gonzalez Monterrey University Hospital
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
INDICASAT SMO / Santo Tomas Hospital, Investigation Department
City
Panamá
ZIP/Postal Code
32401
Country
Panama
Facility Name
St. Joseph Belgorod Regional Clinical Hospital
City
Belgorod
ZIP/Postal Code
308007
Country
Russian Federation
Facility Name
Vinogradov Moscow Municipal Hospital, Department of Surgery #14
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
N.I. Pirogov City Clinical Hospital #1
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Federal State Budget Institution "Central Clinical Hospital with Polyclinic" under the Presidential Executive Office of Russian Federation
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
L.A. Vorokhobov City Clinical Hospital #67
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
City Hospital #33
City
Nizhny Novgorod
ZIP/Postal Code
603076
Country
Russian Federation
Facility Name
Pyatigorsk City Clinical Hospital
City
Pyatigorsk
ZIP/Postal Code
357500
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Zvezdara University Medical Center, Clinic of Internal Diseases, Clinical Department of Nephrology and Metabolic Disorders with Dialysis "Prof. dr Vasilije Jovanovic"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac, Center for Anesthesia and Reanimation
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Worthwhile Clinical Trials, Lakeview Hospital
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Mediclinic Victoria - Practice of R Moodley and MI Sarwan
City
Tongaat
ZIP/Postal Code
4400
Country
South Africa
Facility Name
Hospital del Mar, Department of Intensive Care
City
Barcelona
ZIP/Postal Code
080003
Country
Spain
Facility Name
University Hospital de Elche, Infectious Diseases Unit
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
General University Hospital Gregorio Maranon, Infectious Diseases / Internal Medicine
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
University Hospital Ramon y Cajal, Department of Infectious Diseases
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
University Hospital Mutua de Terrassa, Unit of Infectious Diseases
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Istanbul Kartal Kosuyolu Yuksek Ihtisas Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34846
Country
Turkey
Facility Name
Ondokuz Mayis University School of Medicine, Department of Infectious Diseases
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Dnipropetrovsk City Multispecialty Clinical Hospital #4
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivs'k
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
V.T. Zaitsev Institute of General and Emergency Surgery
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Public Non-Profit Enterprise: O.O. Shalimov City Clinical Hospital #2 under Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital named after N.I. Pirogov Vinnytsia Regional Council"
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
City Clinical Hospital #3
City
Zaporizhzhya
ZIP/Postal Code
69032
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31918579
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7046132/
Description
Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9752497/
Description
Abstract; LB2302. Ceftobiprole Compared to Daptomycin With or Without Optional Aztreonam for the Treatment of Complicated Staphylococcus aureus (SAB): Results of a Phase 3, Randomized, Double-Blind Trial (ERADICATE)

Learn more about this trial

Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

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