Clinical Trials Logo

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.


Clinical Trial 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 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 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


NCT number NCT00228982
Study type Interventional
Source Basilea Pharmaceutica
Contact
Status Completed
Phase Phase 3
Start date October 2004
Completion date December 2005

See also
  Status Clinical Trial Phase
Completed NCT00746109 - Study of Wound Packing After Superficial Skin Abscess Drainage Phase 4
Completed NCT00210899 - Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections Phase 3
Completed NCT00761215 - Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections Phase 2
Completed NCT01967225 - Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections Phase 3
Withdrawn NCT00990392 - Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections N/A
Completed NCT00228410 - Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections Phase 3
Completed NCT05608382 - Effect of an Antiseptic Solution on the Skin Microbiome N/A
Completed NCT03487549 - Cantharidin and Occlusion in Verruca Epithelium Phase 2
Completed NCT02276482 - Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012) Phase 3
Completed NCT00198679 - Effect of Chlorhexidine Skin Cleansing on Skin Flora Phase 4
Completed NCT03981822 - A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts Phase 2
Completed NCT00711802 - Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections Phase 4
Completed NCT00679302 - Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management Phase 4
Completed NCT00488761 - Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI Phase 4
Completed NCT00257036 - A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Mild to Moderate Infections of the Skin and the Supportive Layers Beneath the Skin Phase 2/Phase 3
Completed NCT04485676 - Dalbavancin in Real Clinical Practice in Spain
Completed NCT00785200 - MRSA Colonization and Control in the Dallas County Jail N/A
Completed NCT00257062 - A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Uncomplicated Infections of the Skin and the Supportive Layers Beneath the Skin Phase 3
Completed NCT02582203 - Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA Phase 4
Completed NCT00388310 - Effective Antibiotic Treatment of MRSA N/A