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

Phase 3

Completed

• Conditions: Infection During Hemodialysis
• Interventions: Drug: Ampicillin / sulbactam; Drug: Administration of Amoxicillin / clavulanic acid; Procedure: Blooddraws for pharmacokinetic profiling

• Registration Number: NCT02007603
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Primary Completion: 2015-02
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Age >18 years
• Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
• Renal replacement therapy (HD)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amoxicillin / clavulanic acid	Blooddraws for pharmacokinetic profiling	Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
Ampicillin / sulbactam	Ampicillin / sulbactam	Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
Ampicillin / sulbactam	Blooddraws for pharmacokinetic profiling	Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
Amoxicillin / clavulanic acid	Administration of Amoxicillin / clavulanic acid	Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria