Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections - Tabular View

Tracking Information

First Received Date ^ICMJE

March 4, 2010

Last Updated Date

August 29, 2011

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of sternal wound infection is at least 50% lower if Daptomycin is used on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone [ Time Frame: day 30 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Incidence of sternal wound infection is at least 50% lower if Daptomycin is used on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone

Change History

Complete list of historical versions of study NCT01080963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of sternal wound infections at day 30 after cardiac surgery [ Time Frame: day 30 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Incidence of sternal wound infections at day 30 after cardiac surgery
Safety and tolerance of Daptomycin for prophylaxis

Descriptive Information

Brief Title ^ICMJE

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

Official Title ^ICMJE

Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy

Brief Summary

The purpose of this study is to show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase IV

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Wound Infection

Intervention ^ICMJE

Drug: Daptomycin
one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis

Other Name: Cubicin
Drug: Cefuroxime
1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine

Study Arms

Active Comparator: Daptomycin
Intervention: Drug: Daptomycin
Active Comparator: Cefuroxime
Intervention: Drug: Cefuroxime

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

860

Estimated Completion Date

May 2012

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

age between 18-80
written informed consent (IC)

Exclusion Criteria:

pregnant and lactating women
patients operated for a transplantation
patients with a increased myopathy risk
patients with a creatinine clearance < 30ml/min; patients on hemodialysis
patients after a previous sternotomy
treatment with any antibiotics 14 days prior study start
treatment with Daptomycin or Cefuroxime within 3 month prior study start

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Martin Strueber, Dr.	+49 511 532 3435	Strueber.Martin@mh-hannover.de
Contact: Susanne Freyt	+49 511 532 3450	freyt.susanne@mh-hannover.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01080963

Other Study ID Numbers ^ICMJE

CCBC134ADAPRO, 2007-004611-61

Has Data Monitoring Committee

Responsible Party

Martin Strueber, MD, Hannover Medical School

Study Sponsor ^ICMJE

Hannover Medical School

Collaborators ^ICMJE

Novartis

Investigators ^ICMJE

Principal Investigator:

Martin Strueber, Dr.

Hannover Medical School

Information Provided By

Hannover Medical School

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP