- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210899
Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections
July 25, 2012 updated by: Basilea Pharmaceutica
A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections
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.
The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in patients with complicated skin and skin structure infections.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity.
Ceftobiprole medocaril is not yet approved for the treatment of complicated skin and skin structure infections.
This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with complicated skin and skin structure infections.
The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator.
The patients can be treated as in-patient, out-patient, or through a home agency, at the discretion of the investigator.
The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit.
The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).
Study Type
Interventional
Enrollment (Actual)
828
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of an infection consistent with complicated skin and skin structure infections.
Exclusion Criteria:
- Known or suspected hypersensitivity to any study medication or other related anti-infective 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Vancomycin plus Ceftazidime
Vancomycin 1g q12h as 1h infusions plus Ceftazidime 1g q8h in 2h-infusions, 7-14d
|
|
EXPERIMENTAL: Ceftobiprole medocaril
Ceftobiprole medocaril 500mg q8h as 2h infusions, 7-14d
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7-14 days after the end of therapy.
Time Frame: 7 weeks
|
7-14 days treatment, test of cure assessment at 7-14 days after end of treatment, late follow-up 28-35 days after end of treatment
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (ACTUAL)
October 1, 2006
Study Completion (ACTUAL)
October 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 21, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
July 26, 2012
Last Update Submitted That Met QC Criteria
July 25, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Inflammation
- Disease Attributes
- Connective Tissue Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Staphylococcal Infections
- Suppuration
- Infections
- Communicable Diseases
- Cellulitis
- Skin Diseases, Infectious
- Staphylococcal Skin Infections
- Skin Diseases
- Skin Diseases, Bacterial
- Anti-Infective Agents
- Anti-Bacterial Agents
- Vancomycin
- Ceftazidime
- Ceftobiprole
- Ceftobiprole medocaril
Other Study ID Numbers
- CR005029
- BAP00414 (OTHER: Basilea Pharmaceutica Ltd.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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