Cubicin(R) for Complicated Post-surgical Wound Infections

• Status: Terminated
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Daptomycin

Criteria

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)