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

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

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01219114
• Other study ID #: NIS-IPH-DUM-2010/1
• Status: Withdrawn
• Phase: N/A
• First received: October 10, 2010
• Last updated: September 27, 2011
• Start date: October 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 200
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Philippines	Research Site	Davao City	Davao
Philippines	Research Site	Iloilo City	Iloilo
Philippines	Research Site	Lipa City	Batangas
Philippines	Research Site	Pasig City	Metro Manila
Philippines	Research Site	Quezon City	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events observed during the treatment duration		Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up)	Yes
Primary	Clinical Response determined by cure rate		Ranges from during treatment and up to 14 days after last administration of daptomycin	No