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

This study has been terminated.
(terminated due to slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651131
First Posted: April 2, 2008
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cubicin(R) for Complicated Post-surgical Wound Infections

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals LLC:

Primary Outcome Measures:
  • Investigator's assessment of clinical response based on improvement of signs and symptoms [ Time Frame: End of Therapy ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: first dose to end of therapy ]
  • eradication of pathogens isolated at admission [ Time Frame: End of Therapy ]
  • overall therapeutic outcome based on agreement between clinical efficacy and microbiological response [ Time Frame: End of Therapy ]

Enrollment: 69
Actual Study Start Date: June 1, 2004
Study Completion Date: March 1, 2005
Primary Completion Date: March 1, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00651131     History of Changes
Other Study ID Numbers: 3009-011
DAP-4PSW-03-03 ( Other Identifier: Cubist Study Number )
First Submitted: March 31, 2008
First Posted: April 2, 2008
Last Update Posted: August 30, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Wound Infection
Surgical Wound
Surgical Wound Infection
Postoperative Complications
Pathologic Processes
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents