Cubicin(R) for Complicated Post-surgical Wound Infections (PSW)
Primary Purpose
Wound Infections
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
daptomycin
Sponsored by
About this trial
This is an interventional treatment trial for Wound Infections focused on measuring post-surgical, wound infection, superficial, deep, surgical
Eligibility 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)
Sites / Locations
Outcomes
Primary Outcome Measures
Investigator's assessment of clinical response based on improvement of signs and symptoms
Secondary Outcome Measures
Incidence of adverse events
eradication of pathogens isolated at admission
overall therapeutic outcome based on agreement between clinical efficacy and microbiological response
Full Information
NCT ID
NCT00651131
First Posted
March 31, 2008
Last Updated
August 28, 2017
Sponsor
Cubist Pharmaceuticals LLC
1. Study Identification
Unique Protocol Identification Number
NCT00651131
Brief Title
Cubicin(R) for Complicated Post-surgical Wound Infections
Acronym
PSW
Official Title
Cubicin(R) for Complicated Post-surgical Wound Infections
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
terminated due to slow enrollment
Study Start Date
June 1, 2004 (Actual)
Primary Completion Date
March 1, 2005 (Actual)
Study Completion Date
March 1, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cubist Pharmaceuticals LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infections
Keywords
post-surgical, wound infection, superficial, deep, surgical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
daptomycin
Other Intervention Name(s)
Cubicin, daptomycin for injection, Cubicin (daptomycin for injection)
Intervention Description
daptomycin i.v. 4 mg/kg q24h for 7-14 days
Primary Outcome Measure Information:
Title
Investigator's assessment of clinical response based on improvement of signs and symptoms
Time Frame
End of Therapy
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
first dose to end of therapy
Title
eradication of pathogens isolated at admission
Time Frame
End of Therapy
Title
overall therapeutic outcome based on agreement between clinical efficacy and microbiological response
Time Frame
End of Therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
12. IPD Sharing Statement
Learn more about this trial
Cubicin(R) for Complicated Post-surgical Wound Infections
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