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

September 27, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Batangas
      • Lipa City, Batangas, Philippines
        • Research Site
    • Davao
      • Davao City, Davao, Philippines
        • Research Site
    • Iloilo
      • Iloilo City, Iloilo, Philippines
        • Research Site
    • Metro Manila
      • Pasig City, Metro Manila, Philippines
        • Research Site
      • Quezon City, Metro Manila, Philippines
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

several private and government tertiary hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Milagros Tan, MD, AstraZeneca Philippines
  • Study Chair: Emmanuel Arca, MD, AstraZeneca Philippines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

October 10, 2010

First Submitted That Met QC Criteria

October 10, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-IPH-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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