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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01219114

Enrollment

200

Registered

2010-10-13

Start date

2010-10-31

Completion date

2013-11-30

Last updated

2011-09-28

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

Conditions

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

Keywords

Daptomycin, endocarditis, complicated skin and skin structure infection

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Philippines

Outcome results