Status:
COMPLETED
Temocillin Pharmacokinetic in Hemodialysis
Lead Sponsor:
AZ Sint-Jan AV
Collaborating Sponsors:
Paul Tulkens, Louvain drug research institute, belgium
Francoise Van Bambeke, Louvain drug research institute, belgium
Conditions:
Gram-Negative Bacterial Infections
Renal Failure Chronic Requiring Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The current study aimed to explore the pharmacokinetics of temocillin in patients treated with haemodialysis and to demonstrated whether or not the pharmacodynamics target of a time above a MIC of 16 ...
Detailed Description
Background: Temocillin is a renally cleared penicillin with long serum half-live and potent activity against most gram-negative bacteria, making it an ideal candidate for treatment given on dialysis d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02285075
Start Date
June 1 2011
End Date
December 1 2014
Last Update
January 5 2016
Active Locations (2)
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1
AZ Sint-Jan Brugge Oostende AV
Bruges, Belgium, 8000
2
Louvain Drug Research Institute (LDRI)
Brussels, Belgium, 1020