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
Summary
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Medical University of Vienna, Vienna 1090, Austria
Additional Information
Starting date: August 2013
Last updated: July 17, 2015
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