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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: |
NCT00488813 |
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Date of registration:
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18/06/2007 |
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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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Study of Antibiotic Utilization Measures and Control of ESBLs in China
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Scientific title:
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Association of Antibiotic Utilization Measures and Control of Extended-spectrum ß-lactamases (ESBLs) in MICU1 and MICU2 at Buddhist Tzu Chi General Hospital. |
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Date of first enrolment:
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July 2004 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00488813 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Taiwan, medinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients admitted or transferred to the ICU/burn units.
- Patients of either sex, 18 years of age or older.
Exclusion Criteria:
- Patient with hypersensitivity to penicillins, cephalosporins, and beta-lactamase
inhibitors.
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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ICU Patient
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Intervention(s)
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Drug: Third generation cephalosporins
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Primary Outcome(s)
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For both MICU1 and MICU2 (acquisition), all culture results will be collected and recorded, then analyzed to determine the ESBL acquisition rate and bacterial isolates (E. coli or K. pneumoniae).
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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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