Cubicin(R) for Complicated Post-surgical Wound Infections

Study Overview
=================
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.

Official Title
-----------------
Cubicin(R) for Complicated Post-surgical Wound Infections

Conditions
-----------------
Wound Infections

Intervention / Treatment
-----------------
* Drug: daptomycin


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: daptomycin|daptomycin i.v. 4 mg/kg q24h for 7-14 days|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's assessment of clinical response based on improvement of signs and symptoms |  | End of Therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | first dose to end of therapy | 
| eradication of pathogens isolated at admission |  | End of Therapy | 
| overall therapeutic outcome based on agreement between clinical efficacy and microbiological response |  | End of Therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-surgical, wound infection, superficial, deep, surgical