Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
2 other identifiers
interventional
784
0 countries
N/A
Brief Summary
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated skin and skin structure infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 27, 2005
CompletedFirst Posted
Study publicly available on registry
September 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJuly 26, 2012
July 1, 2012
1.2 years
September 27, 2005
July 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical outcome (cure, failure, not evaluable) at 7-14 days after the end of therapy.
7 weeks
Secondary Outcomes (1)
Microbiological outcome at 7-14 days after the end of therapy. Clinical and microbiological outcome at late follow-up visit. Evolution of signs and symptoms of disease. Time to clinical cure. Safety and tolerability evaluations during the study.
7 weeks
Study Arms (2)
Ceftobiprole medocaril
EXPERIMENTALCeftobiprole medocaril 500mg q12h as 1h infusion, 7-14d
Vancomycin
ACTIVE COMPARATORVancomycin 1g q12h as 1h infusion, 7-14d
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of an infection consistent with complicated skin and skin structure infections.
You may not qualify if:
- Known or suspected hypersensitivity to any study medication
- Any known or suspected condition or concurrent treatment contraindicated by the prescribing information
- Previous enrollment in this study
- Treatment with any investigational drug within 30 days before enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2005
First Posted
September 29, 2005
Study Start
October 1, 2004
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
July 26, 2012
Record last verified: 2012-07