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Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

NCT01080963 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2012-04-17

No results posted yet for this study

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.

Conditions

  • Wound Infection

Interventions

DRUG

Daptomycin

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

DRUG

Cefuroxime

1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Martin Strueber, Dr. · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01080963 on ClinicalTrials.gov