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Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138733
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Basilea Pharmaceutica

Brief 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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Bacteremia Drug: Ceftobiprole medocaril Drug: Daptomycin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin

Arm Intervention/treatment
Experimental: Ceftobiprole medocaril
Ceftobiprole medocaril 500 mg
Drug: Ceftobiprole medocaril
Ceftobiprole medocaril 500 mg as 2 h infusion

Active Comparator: Daptomycin
Daptomycin 6 mg/kg, with or without Aztreonam
Drug: Daptomycin
Daptomycin 6 mg/kg as 0.5 h infusion, with or without Aztreonam




Primary Outcome Measures :
  1. Overall success at the post-treatment evaluation (PTE) visit [ Time Frame: Day 70±5 ]
    Comparison of overall success rates in the modified intent-to-treat (mITT) population


Secondary Outcome Measures :
  1. All-cause mortality at the PTE visit [ Time Frame: Day 70±5 ]
    Comparison of all-cause mortality rates in the mITT population

  2. Microbiological eradication at the PTE visit [ Time Frame: Day 70±5 ]
    Comparison of microbiological eradication rates in the mITT population

  3. Overall success at the PTE visit [ Time Frame: Day 70±5 ]
    Comparison of overall success rates in the clinically evaluable (CE) population

  4. Development of new metastatic foci or other complications of SAB after Day 7 [ Time Frame: Day 70±5 ]
    Comparison of complication rates in the mITT population

  5. Time to Staphylococcus aureus bloodstream clearance [ Time Frame: Up to 6 weeks ]
    Time-to-event comparison in the mITT and CE populations

  6. Incidence, type, severity, and relationship to study medication of adverse events; and changes in laboratory tests [ Time Frame: Up to Day 70±5 ]
    Treatment-emergent adverse events; safety laboratory tests

  7. Ceftobiprole maximum plasma concentration [ Time Frame: Day 3 and Day 12 ]
    Ceftobiprole plasma concentrations at various time points

  8. Ceftobiprole area under the concentration-time curve [ Time Frame: Day 3 and Day 12 ]
    Ceftobiprole plasma concentrations at various time points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138733


Contacts
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Contact: Kamal Hamed, MD, MPH +41 61 567 15 88 kamal.hamed@basilea.com
Contact: Marc Engelhardt, MD +41 61 567 15 46 marc.engelhardt@basilea.com

Locations
Show Show 74 study locations
Sponsors and Collaborators
Basilea Pharmaceutica
Department of Health and Human Services
Investigators
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Study Director: Kamal Hamed, MD, MPH Basilea Pharmaceutica
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT03138733    
Other Study ID Numbers: BPR-CS-009
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Daptomycin
Ceftobiprole
Ceftobiprole medocaril
Anti-Bacterial Agents
Anti-Infective Agents