Cubicin(R) for Complicated Post-surgical Wound Infections (PSW)

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase

Terminated

Phase 4

Conditions

Wound Infections

Treatments

Drug: daptomycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00651131

DAP-4PSW-03-03 (Other Identifier)

3009-011

Details and patient eligibility

About

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

Full 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.

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)