Safety and Efficacy Study of CUBICIN (Daptomycin) Under Conditions of Actual Use

AstraZeneca

Status: Withdrawn

Conditions: Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis

Study type: Observational

Funder types: Industry

Identifiers

NCT01219114

NIS-IPH-DUM-2010/1

Details and patient eligibility

About

The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are prescribed CUBICIN by their physician.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cSSSI known or suspected to be due to gram-positive bacteria
• Diagnosis of right-sided endocarditis with one or more positive culture for S. aureus within two days prior to initiation of medication
• Prescribed daptomycin by patient's attending physician

Exclusion criteria

• Known allergic or serious adverse reaction to daptomycin
• Patients with pneumonia
• Patients with baseline CPK values >1000 U/L or 5x ULN

Trial design

200 participants in 1 patient group

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