Daptomycin in Wound Infections - Clinical Trials Registry

Study Overview

Status

Terminated

Conditions

Wound Infections

Intervention / Treatment

Drug: daptomycin

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 Type

Interventional

Enrollment (Actual)

69

Phase

Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cubist Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria