Concentration of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid in the Blood During Renal Replacement Therapy in Longterm Renal Replacement Therapy Patients
NCT ID: NCT02007603
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
16 participants
INTERVENTIONAL
2013-08-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ampicillin / sulbactam
Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
Ampicillin / sulbactam
Patients receive ampicillin / sulbactam due to clinical necessity
Blooddraws for pharmacokinetic profiling
Blood will be sampled at multiple timepoints during multiple hemodialysis sessions
Amoxicillin / clavulanic acid
Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
Administration of Amoxicillin / clavulanic acid
Patients receive amoxicillin / clavulanic acid due to clinical necessity
Blooddraws for pharmacokinetic profiling
Blood will be sampled at multiple timepoints during multiple hemodialysis sessions
Interventions
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Administration of Amoxicillin / clavulanic acid
Patients receive amoxicillin / clavulanic acid due to clinical necessity
Ampicillin / sulbactam
Patients receive ampicillin / sulbactam due to clinical necessity
Blooddraws for pharmacokinetic profiling
Blood will be sampled at multiple timepoints during multiple hemodialysis sessions
Eligibility Criteria
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Inclusion Criteria
* Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
* Renal replacement therapy (HD)
Exclusion Criteria
* An expected survival of less than two days.
* Known pregnancy
* Co-administration of one of the following drugs: probenecid which cannot be discontinued for the duration of the study
* Ampicillin / sulbactam respectively amoxicillin / clavulanic acid as monotherapy for resistant species or fungal infections.
* Other reasons opposing the study participation on the discretion of the investigators.
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Florian Thalhammer
a.o.Univ.-Prof. Dr.
Principal Investigators
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Florian Thalhammer, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Other Identifiers
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AMPISUL/AMOXICLAV-HD_V1.4
Identifier Type: -
Identifier Source: org_study_id
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