Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections - Full Text View

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections (DaPro)

This study is currently recruiting participants.

Verified by Hannover Medical School, March 2010

First Received: March 4, 2010 Last Updated: March 18, 2010 History of Changes

Sponsor:	Hannover Medical School
Collaborator:	Novartis
Information provided by:	Hannover Medical School
ClinicalTrials.gov Identifier:	NCT01080963

Purpose

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.

Condition	Intervention	Phase
Wound Infection	Drug: Daptomycin Drug: Cefuroxime	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Cefuroxime Cefuroxime sodium Cefuroxime axetil Daptomycin

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	860
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Daptomycin: Active Comparator	Drug: Daptomycin one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis
Cefuroxime: Active Comparator	Drug: Cefuroxime 1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080963

Contacts

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

Locations

Germany
Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery	Recruiting
Hannover, Germany
Contact: Susanne Freyt +49 511 532 3450 freyt.susanne@mh-hannover.de
Principal Investigator: Martin Strueber, Dr.

Sponsors and Collaborators

Hannover Medical School

Novartis

Investigators

Principal Investigator:

Martin Strueber, Dr.

Hannover Medical School

More Information

No publications provided

Responsible Party:	Hannover Medical School ( Martin Strueber, MD )
ClinicalTrials.gov Identifier:	NCT01080963 History of Changes
Other Study ID Numbers:	CCBC134ADAPRO, 2007-004611-61
Study First Received:	March 4, 2010
Last Updated:	March 18, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:

Prophylaxis
Antibiotic
Sternotomy
Heart-Lung Machine

Additional relevant MeSH terms:

Wound Infection
Infection
Wounds and Injuries
Disorders of Environmental Origin
Anti-Bacterial Agents
Cefuroxime

Cefuroxime axetil
Daptomycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2010