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

NCT ID: NCT01219114

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Milagros Tan, MD

Role: STUDY_DIRECTOR

AstraZeneca Philippines

Emmanuel Arca, MD

Role: STUDY_CHAIR

AstraZeneca Philippines

Locations

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Research Site

Lipa City, Batangas, Philippines

Site Status

Research Site

Davao City, Davao Region, Philippines

Site Status

Research Site

Iloilo City, Iloilo, Philippines

Site Status

Research Site

Pasig, National Capital Region, Philippines

Site Status

Research Site

Quezon City, National Capital Region, Philippines

Site Status

Countries

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Philippines

Other Identifiers

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NIS-IPH-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id