Overview

This trial is active, not recruiting.

Condition infection during hemodialysis
Treatments administration of amoxicillin / clavulanic acid, ampicillin / sulbactam, blooddraws for pharmacokinetic profiling
Phase phase 3
Sponsor Medical University of Vienna
Start date August 2013
End date February 2015
Trial size 16 participants
Trial identifier NCT02007603, AMPISUL/AMOXICLAV-HD_V1.4

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
(Experimental)
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

Primary Outcomes

Measure
Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels.
time frame: day 15

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Multiple-dose Pharmacokinetics of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid During Haemodialysis in Longterm Haemodialysis Patients
Principal investigator Florian Thalhammer, Prof. MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Medical University of Vienna.