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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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18 January 2016 |
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Main ID: |
NCT02285075 |
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Date of registration:
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02/11/2014 |
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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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Temocillin Pharmacokinetic in Hemodialysis
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Scientific title:
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A Clinical Pharmacokinetic Study: Is Three Times Weekly Temocillin Appropriate for the Treatment of Severe Gram-negative Infections in Patients With ESRD Treated With Intermittent Hemodialysis? |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02285075 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Stefaan J Vandecasteele, 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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AZ Sint-Jan AV |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- all patients under treatment with haemodialysis for ESRD for whom a treatment with
temocillin was indicated according to the attending physician were eligible for the
study.
Exclusion Criteria:
- an age of less than 18 years
- an estimated life-expectance of < 24 hours due to major co-morbid conditions
- pregnancy
- an IgE-mediated allergy to penicillins
- patients not giving informed consent.
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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Gram-Negative Bacterial Infections
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Renal Failure Chronic Requiring Hemodialysis
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Intervention(s)
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Drug: temocillin PK/PD in haemodialysis
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Primary Outcome(s)
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% of the dosing interval time above an MIC of 8 and 16 mg/L (% T>MIC 8 or 16 mg/L)
[Time Frame: two to ten days]
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Secondary Outcome(s)
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Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis
[Time Frame: two to ten days]
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Secondary ID(s)
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SVDC Temocillin 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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