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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01219114 |
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Date of registration:
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10/10/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of CUBICIN (Daptomycin) Under Conditions of Actual Use
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Scientific title:
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A Descriptive Study of the Efficacy and Safety of CUBICIN (Daptomycin) Under Conditions of Actual Use in the Philippines |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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200 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01219114 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Milagros Tan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca Philippines |
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Name:
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Emmanuel Arca, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca Philippines |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Complicated Skin and Skin Structure Infections and Bacteremia Including Right-sided Endocarditis
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Primary Outcome(s)
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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)]
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Clinical Response determined by cure rate
[Time Frame: Ranges from during treatment and up to 14 days after last administration of daptomycin]
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Secondary ID(s)
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NIS-IPH-DUM-2010/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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