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

This study has been terminated.
(terminated due to slow enrollment)
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00651131
First received: March 31, 2008
Last updated: June 24, 2009
Last verified: June 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Wound Infections
 Drug: daptomycin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cubicin(R) for Complicated Post-Surgical Wound Infections

Resource links provided by NLM:

Drug Information available for: Daptomycin
U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Investigator's assessment of clinical response based on improvement of signs and symptoms [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: first dose to end of therapy ] [ Designated as safety issue: Yes ]
  • eradication of pathogens isolated at admission [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]
  • overall therapeutic outcome based on agreement between clinical efficacy and microbiological response [ Time Frame: End of Therapy ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: June 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: daptomycin
    daptomycin i.v. 4 mg/kg q24h for 7-14 days
    Other Names:
    • Cubicin
    • daptomycin for injection
    • Cubicin (daptomycin for injection)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ed Campanaro, Vice President Clinical Operations and Data Management, Cubist Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00651131     History of Changes
Other Study ID Numbers: DAP-4PSW-03-03
Study First Received: March 31, 2008
Last Updated: June 24, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Cubist Pharmaceuticals:
post-surgical
wound infection
superficial
deep
surgical

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
 Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013