Status:
TERMINATED
Cubicin(R) for Complicated Post-surgical Wound Infections
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Wound Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. A...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00651131
Start Date
June 1 2004
End Date
March 1 2005
Last Update
August 30 2017
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