Concentration of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid in the Blood During Renal Replacement Therapy in Longterm Renal Replacement Therapy Patients

Study Overview
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Brief Summary
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The study will be conducted to investigate the pharmacokinetics of ampicillin / sulbactam and amoxicillin/clavulanic acid during intermittent haemodialysis.

Official Title
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Multiple-dose Pharmacokinetics of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid During Haemodialysis in Longterm Haemodialysis Patients

Conditions
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Infection During Hemodialysis

Intervention / Treatment
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* Drug: Administration of Amoxicillin / clavulanic acid
* Drug: Ampicillin / sulbactam
* Procedure: Blooddraws for pharmacokinetic profiling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Suspected or proven bacterial infection requiring parenteral antibiotic therapy. Renal replacement therapy (HD) Exclusion Criteria: Known hypersensitivity to ampicillin / sulbactam, amoxicillin / clavulanic acid or other beta-lactames, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ampicillin / sulbactam<br>Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions. | Drug: Ampicillin / sulbactam<br>* Patients receive ampicillin / sulbactam due to clinical necessity<br>Procedure: Blooddraws for pharmacokinetic profiling<br>* Blood will be sampled at multiple timepoints during multiple hemodialysis sessions<br>|
| Experimental: Amoxicillin / clavulanic acid<br>Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions. | Drug: Administration of Amoxicillin / clavulanic acid<br>* Patients receive amoxicillin / clavulanic acid due to clinical necessity<br>Procedure: Blooddraws for pharmacokinetic profiling<br>* Blood will be sampled at multiple timepoints during multiple hemodialysis sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels. | Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation. | day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hemodialysis, ampicillin, sulbactam, amoxicillin, clavulanic acid, pharmacokinetics