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Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

NCT03138733 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2023-11-08

Study results available
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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).

Conditions

  • Staphylococcus Aureus Bacteremia

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

Sponsors & Collaborators

Principal Investigators

  • Marc Engelhardt, MD · Basilea Pharmaceutica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-26
Primary Completion
2022-03-11
Completion
2022-03-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Colombia
  • Georgia
  • Germany
  • Greece
  • Israel
  • Italy
  • Mexico
  • Panama
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03138733 on ClinicalTrials.gov