Cubicin(R) for Complicated Post-surgical Wound Infections

Phase 4

Terminated

• Conditions: Wound Infections

• Registration Number: NCT00651131
• Lead Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief Summary

The purpose of the study is to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections

Detailed Description

A multi-center, single-arm, open-label, non-comparative study to describe the clinical efficacy of CUBICIN therapy in patients with superficial and deep post-surgical Gram-positive wound infections. Adjunctive treatment with aztreonam and/or metronidazole could be given for Gram-negative and/or anaerobic organisms. Patients are to be treated for a period of 7-14 days as specified in the package insert. An evaluation is to be performed on the day CUBICIN treatment is completed (assessment for outcome of cure, improved, failure or unable to evaluate). A follow-up is required for patients with an Investigator response of 'Improved' at the end of treatment.

Study Timeline

• Study Start: 2004-06-01
• Primary Completion: 2005-03-01
• Study Completion: 2005-03-01
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-02
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Read and signed informed consent form
• female of childbearing potential, negative pregnancy test result
• Confirmed diagnosis of post-surgical wound infections known or suspected (based on Gram stain) to be due to Gram-positive organisms obtained within 3 calendar days prior to first dose of study medication
• Onset of surgical wound infection within 30 days after surgery
• At least three clinical signs and symptoms of skin infection

Exclusion Criteria

• previous systemic antimicrobial therapy exceeding 24 hours duration administered anytime during 72 hours prior to the first dose of study drug
• Uncomplicated surgical infections (eg, stitch abscesses)
• osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection
• Any type of space infection
• Conditions requiring surgical removal of wound infection
• necrotizing fasciitis, synergistic gangrene, Clostridial myonecrosis (gas gangrene), or Fournier's gangrene;
• Foreign material involved in the post-surgical wound infection
• Known to be allergic or intolerant to study medication
• Creatinine Clearance (CLCR) <30 mL/min
• history of neurological disease (eg, Guillain-Barré, multiple sclerosis)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Investigator's assessment of clinical response based on improvement of signs and symptoms	End of Therapy

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	first dose to end of therapy
eradication of pathogens isolated at admission	End of Therapy
overall therapeutic outcome based on agreement between clinical efficacy and microbiological response	End of Therapy