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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02007603

Enrollment

Registered

2013-12-11

Start date

2013-08-31

Completion date

2017-05-31

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection During Hemodialysis

Keywords

chronic hemodialysis, ampicillin, sulbactam, amoxicillin, clavulanic acid, pharmacokinetics

Brief summary

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

Interventions

DRUGAdministration of Amoxicillin / clavulanic acid

Patients receive amoxicillin / clavulanic acid due to clinical necessity

DRUGAmpicillin / sulbactam

Patients receive ampicillin / sulbactam due to clinical necessity

PROCEDUREBlooddraws for pharmacokinetic profiling

Blood will be sampled at multiple timepoints during multiple hemodialysis sessions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026