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OpenTrials
Completed

NCT Number: NCT02007603

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

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

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Key information

Conditions

Infection During Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Administration of Amoxicillin / clavulanic acid

Drug

Patients receive amoxicillin / clavulanic acid due to clinical necessity

Ampicillin / sulbactam

Drug

Patients receive ampicillin / sulbactam due to clinical necessity

Blooddraws for pharmacokinetic profiling

Procedure

Blood will be sampled at multiple timepoints during multiple hemodialysis sessions

Primary outcomes

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

    Time frame: day 15

    Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Dec 11, 2013
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.