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

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (Inability to recruit patients within the specified time period.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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Group/Cohort
1



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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01219114


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

Responsible Party: AstraZeneca
ClinicalTrials.gov 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:
Daptomycin
endocarditis
complicated skin and skin structure infection

Additional relevant MeSH terms:
Endocarditis
Bacterial Infections
Infection
Anti-Bacterial Agents
Bacteremia
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Daptomycin
Anti-Infective Agents