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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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7 November 2016 |
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Main ID: |
NCT02560207 |
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Date of registration:
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22/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.
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Scientific title:
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Does Continuous Cefotaxime Administration Improve Time to Attainment and Maintenance of Target Drug Levels in Critically Ill Patients? |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02560207 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Jan G Zijlstra, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Critical Care, UMCG |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Admitted to intensive care
- Able to give informed consent by themselves or informed consent can be obtained via
next of kin
- Indication for treatment with cefotaxime (as judged by treating physician) in the
context of our standard treatment protocol of Selective decontamination of the
digestive tract (SDD).
Exclusion Criteria:
- Renal replacement therapy
- Contra-indication for cefotaxime, including known or suspected allergy to cefotaxime
- No indication for an arterial line; an arterial line will not be placed solely for
the purpose of this study; thus, only patients with an indication for an arterial
line outside this protocol are eligible.
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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Critically Ill
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Intervention(s)
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Drug: Cefotaxime
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Primary Outcome(s)
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Cefotaxim serum concentrations
[Time Frame: 40 min, 1 hour, 2, 4, 8, 12 and 24 hours; 36h; 48 h; 60h; 72h; 84h and 96h post administration]
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Secondary Outcome(s)
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Area under the curve of cefotaxim
[Time Frame: 0-96h post administration]
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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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