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NCT00210899 Clinical Trial

Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections

Skin Diseases, Infectious Clinical Trial

Official title:
A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00210899
Other study ID # CR005029
Secondary ID BAP00414
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated July 25, 2012
Start date September 2005
Est. completion date October 2006

Study information
Verified date July 2012
Source Basilea Pharmaceutica
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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. The study will also characterize the safety and tolerability of treatment with ceftobiprole medocaril in patients with complicated skin and skin structure infections.

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).

Recruitment information / eligibility
Status Completed
Enrollment 828
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ceftobiprole medocaril

• Vancomycin plus Ceftazidime

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Basilea Pharmaceutica

References & Publications (1)

Noel GJ, Bush K, Bagchi P, Ianus J, Strauss RS. A randomized, double-blind trial comparing ceftobiprole medocaril with vancomycin plus ceftazidime for the treatment of patients with complicated skin and skin-structure infections. Clin Infect Dis. 2008 Mar — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 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 No
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