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

Withdrawn

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

• Registration Number: NCT01219114
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-10
• Study First Submitted QC: 2010-10-10
• Study First Posted: 2010-10-13
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-28
• Primary Completion: 2013-10
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events observed during the treatment duration	Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up)
Clinical Response determined by cure rate	Ranges from during treatment and up to 14 days after last administration of daptomycin

Trial Locations

Locations (1)

Research Site; 🇵🇭 Quezon City, Metro Manila, Philippines