Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections (DaPro)

Hannover Medical School (MHH)

Status and phase: Completed; Phase 4

Conditions: Wound Infection

Treatments: Drug: Daptomycin; Drug: Cefuroxime

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01080963

CCBC134ADAPRO

2007-004611-61 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 650 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

Daptomycin

Active Comparator group

Treatment:

Drug: Daptomycin

Cefuroxime

Active Comparator group

Treatment:

Drug: Cefuroxime