Cubicin(R) for Complicated Post-surgical Wound Infections

NCT ID: NCT00651131

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-01
• Study Completion Date: 2005-03-01

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.

Conditions

Wound Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

daptomycin

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

Intervention Type: DRUG

Other Intervention Names

Cubicin; daptomycin for injection; Cubicin (daptomycin for injection)

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DAP-4PSW-03-03

Identifier Type: OTHER

Identifier Source: secondary_id

3009-011

Identifier Type: -

Identifier Source: org_study_id