A Pilot Study of Daptomycin for Antimicrobial Prophylaxis - Full Text View

Sponsors and Collaborators:	Duke University Cubist Pharmaceuticals
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00572260

Purpose

The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of surgical site infection, and to evaluate the occurrence of adverse events.

Condition	Intervention	Phase
Staphylococcal Infections	Drug: daptomycin 6 mg/kg IV	Phase IV

MedlinePlus related topics: Coronary Artery Bypass Surgery Staphylococcal Infections

Drug Information available for: Daptomycin Methicillin Methicillin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Factorial Assignment, Efficacy Study
Official Title:	A Pilot Study of Daptomycin for Antimicrobial Prophylaxis in Patients Undergoing Cardiac Valve Replacement and Coronary Artery Bypass Grafting (CABG) Who Are at Increased Risk for Infection Due to Methicillin-Resistant Staphylococcus Aureus (MRSA)

Further study details as provided by Duke University:

Primary Outcome Measures:

The primary endpoint is the rate of patients receiving antimicrobial prophylaxis within the appropriate timeframe before surgical incision in the daptomycin arm. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of appropriate administration between daptomycin patients and a group of historical controls who received vancomycin prophylaxis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Rates of post-operative infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	December 2007
Study Completion Date:	May 2008

Arms	Assigned Interventions
A: Experimental Daptomycin as a single preoperative dose within 30 minutes prior to surgery Dosage: if creatinine clearance ≥ 30 ml/min: 6 mg/kg IV	Drug: daptomycin 6 mg/kg IV daptomycin 6 mg/kg IV given during induction phase as a one-time prophylactic dose for patients undergoing cardiac valve replacement and coronary artery bypass grafting (CABG) who are at increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)
B: No Intervention A historical cohort of 100 randomly selected patients who underwent cardiac surgery and received vancomycin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572260

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Cubist Pharmaceuticals

Investigators

Principal Investigator:

Keith S Kaye, MD, MPH

DUMC

More Information

Responsible Party:	Duke University Medical Center ( Keith Kaye, MD )
Study ID Numbers:	Pro00000856, 19497
Study First Received:	December 12, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00572260
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

MRSA
cardiac valve replacement
coronary artery bypass grafting (CABG)
increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)

Study placed in the following topic categories:

Daptomycin
Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Methicillin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009