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Prospektive, randomisierte, monozentrische 2-armige Studie zum Einsatz von Daptomycin in der antibiotischen Prophylaxe von sternalen Wundinfektionen nach medianer Sternotomie - DaPro - Daptomycin in der antibiotischen Prophylaxe sternaler Wundinfektionen

Prospektive, randomisierte, monozentrische 2-armige Studie zum Einsatz von Daptomycin in der antibiotischen Prophylaxe von sternalen Wundinfektionen nach medianer Sternotomie - DaPro - Daptomycin in der antibiotischen Prophylaxe sternaler Wundinfektionen

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004611-61-DE
Enrollment
Unknown
Registered
2007-10-31
Start date
2008-08-19
Completion date
Unknown
Last updated
2013-05-20

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

Conditions

Incidence of sternal wound infections after cardiac surgery via median sternectomy and use of the heart-lung machine. MedDRA version: 9.1 Level: LLT Classification code 10036410 Term: Postoperative wound infection MedDRA version: 9.1 Level: LLT Classification code 10053562 Term: Surgical wound infection MedDRA version: 9.1 Level: LLT Classification code 10054091 Term: Wound infection due to staphylococcus aureus MedDRA version: 9.1 Level: LLT Classification code 10059442 Term: Wound infectio

Interventions

Trade Name: Cubicin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: DAPTOMYCIN CAS Number: 103060533 Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Sponsors

Medizinische Hochschule Hannover (MHH)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: * female and male patients having a cardiac surgery involving median sternectomy and the use of the heart-lung-machine * age: 18 - 65 years * written IC Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * pregnant and lactating women * patients operated for a transplantation * patients with a increased myopathy risk * patients with a creatinine clearance < 30 ml/min; patients on hemodialysis * patients after a previous sternectomy * treatment with any antibioticum 14 days prior study start * treatment with Daptomycin or Cefuroxim within 3 month prior study start

Design outcomes

Primary

MeasureTime frame
Main Objective: 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. ;Secondary Objective: - incidence of sternal wound infections at day 30 after cardiac surgery - safety and tolerability of Daptomycin in the setting of prophylactic use;Primary end point(s): To show that the incidence of sternal wound infections is at least 50% lower if Daptomycin is used on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026