Cubicin(R) for Complicated Post-surgical Wound Infections

Wound Infections Clinical Trial

— PSW  

Official title:

Cubicin(R) for Complicated Post-surgical Wound Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00651131
• Other study ID #: 3009-011
• Secondary ID: DAP-4PSW-03-03
• Status: Terminated
• Phase: Phase 4
• First received: March 31, 2008
• Last updated: August 28, 2017
• Start date: June 1, 2004
• Est. completion date: March 1, 2005

Study information

• Verified date: August 2017
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: March 1, 2005
• Est. primary completion date: March 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Wound Infection
• Wound Infection
• Wound Infections
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's assessment of clinical response based on improvement of signs and symptoms		End of Therapy
Secondary	Incidence of adverse events		first dose to end of therapy
Secondary	eradication of pathogens isolated at admission		End of Therapy
Secondary	overall therapeutic outcome based on agreement between clinical efficacy and microbiological response		End of Therapy