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

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection During Hemodialysis

Intervention: Administration of Amoxicillin / clavulanic acid (Drug); Ampicillin / sulbactam (Drug); Blooddraws for pharmacokinetic profiling (Procedure)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Florian Thalhammer, Prof. MD, Principal Investigator, Affiliation: Medical University of Vienna


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

Medical University of Vienna, Vienna 1090, Austria
Additional Information

Starting date: August 2013
Last updated: July 17, 2015

Page last updated: August 23, 2015

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