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Status: Withdrawn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 durationClinical 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
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