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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01219114
Recruitment Status : Withdrawn (Inability to recruit patients within the specified time period. No patients have been enrolled in the study.)
First Posted : October 13, 2010
Last Update Posted : September 28, 2011
Information provided by (Responsible Party):

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.

Condition or disease
Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis

Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: A Descriptive Study of the Efficacy and Safety of CUBICIN (Daptomycin) Under Conditions of Actual Use in the Philippines
Study Start Date : October 2010
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis
Drug Information available for: Daptomycin


Primary Outcome Measures :
  1. 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) ]
  2. Clinical Response determined by cure rate [ Time Frame: Ranges from during treatment and up to 14 days after last administration of daptomycin ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
several private and government tertiary hospitals

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01219114

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
Sponsors and Collaborators
Study Director: Milagros Tan, MD AstraZeneca Philippines
Study Chair: Emmanuel Arca, MD AstraZeneca Philippines

Responsible Party: AstraZeneca Identifier: NCT01219114     History of Changes
Other Study ID Numbers: NIS-IPH-DUM-2010/1
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011

Keywords provided by AstraZeneca:
complicated skin and skin structure infection

Additional relevant MeSH terms:
Bacterial Infections
Anti-Bacterial Agents
Systemic Inflammatory Response Syndrome
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Anti-Infective Agents