Cubicin(R) for Complicated Post-surgical Wound Infections

ID: NCT00651131
Status: Terminated
Phase: Phase 4
Start Date: June 01, 2004
First Submitted: March 31, 2008
Last Updated: August 28, 2017
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC
Location: N/A
Conditions: Wound Infections
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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.
Condition or disease Intervention/treatment Phase

Wound Infections

Drug: daptomycin
Other Names
Cubicin daptomycin for injection Cubicin (daptomycin for injection)
Phase 4

Tracking Information

First Submitted DateMarch 31, 2008
Last Update Posted DateAugust 28, 2017
Actual Start DateJune 01, 2004
Actual Completion DateMarch 01, 2005
Actual Primary Completion DateMarch 01, 2005
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

Current 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleCubicin(R) for Complicated Post-surgical Wound Infections
Official TitleCubicin(R) for Complicated Post-surgical Wound Infections
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.

Study TypeInterventional
Study PhasePhase 4
Estimated Enrollment
69
Allocation
Randomized
Interventional Model
Single Group Assignment
Masking
None
Primary Purpose
Treatment
Conditions
Wound Infections
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: daptomycin

daptomycin i.v. 4 mg/kg q24h for 7-14 days

Other Names
Cubicin
daptomycin for injection
Cubicin (daptomycin for injection)
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Terminated
Enrollment69
Completion DateMarch 01, 2005
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)
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT00651131
Other Study ID Numbers
3009-011
DAP-4PSW-03-03
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
Not Available
Investigators
Not Available