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

May 29, 2017 updated by: Florian Thalhammer, Medical University of Vienna

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ampicillin / sulbactam
Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
Drug: Ampicillin / sulbactam
Patients receive ampicillin / sulbactam due to clinical necessity
Procedure: Blooddraws for pharmacokinetic profiling
Blood will be sampled at multiple timepoints during multiple hemodialysis sessions
EXPERIMENTAL: Amoxicillin / clavulanic acid
Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.
Procedure: Blooddraws for pharmacokinetic profiling
Blood will be sampled at multiple timepoints during multiple hemodialysis sessions
Drug: Administration of Amoxicillin / clavulanic acid
Patients receive amoxicillin / clavulanic acid due to clinical necessity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Florian Thalhammer, Prof. MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2013

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 29, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMPISUL/AMOXICLAV-HD_V1.4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection During Hemodialysis

Clinical Trials on Ampicillin / sulbactam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe