Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01080963

Acronym

DaPro

Enrollment

650

Registered

2010-03-05

Start date

2008-11-30

Completion date

2012-03-31

Last updated

2012-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Infection

Keywords

Prophylaxis, Antibiotic, Sternotomy, Heart-Lung Machine

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.

Interventions

DRUGDaptomycin

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

DRUGCefuroxime

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	day 30

Secondary

Measure	Time frame
Incidence of sternal wound infections at day 30 after cardiac surgery	day 30

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026