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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis

Phase: N/A

Status: Withdrawn

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Milagros Tan, MD, Study Director, Affiliation: AstraZeneca Philippines
Emmanuel Arca, MD, Study Chair, Affiliation: AstraZeneca Philippines

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.

Clinical Details

Official title: A Descriptive Study of the Efficacy and Safety of CUBICIN (Daptomycin) Under Conditions of Actual Use in the Philippines

Study design: Time Perspective: Prospective

Primary outcome:

Adverse events observed during the treatment duration

Clinical Response determined by cure rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Lipa City, Batangas, Philippines

Research Site, Davao City, Davao, Philippines

Research Site, Iloilo City, Iloilo, Philippines

Research Site, Pasig City, Metro Manila, Philippines

Research Site, Quezon City, Metro Manila, Philippines

Additional Information

Starting date: October 2010
Last updated: September 27, 2011

Page last updated: August 20, 2015

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