Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02007603
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Florian Thalhammer, Medical University of Vienna

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

Condition or disease Intervention/treatment Phase
Infection During Hemodialysis Drug: Administration of Amoxicillin / clavulanic acid Drug: Ampicillin / sulbactam Procedure: Blooddraws for pharmacokinetic profiling Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiple-dose Pharmacokinetics of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid During Haemodialysis in Longterm Haemodialysis Patients
Actual Study Start Date : August 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2017


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.
Drug: Administration of Amoxicillin / clavulanic acid
Patients receive amoxicillin / clavulanic acid due to clinical necessity

Procedure: Blooddraws for pharmacokinetic profiling
Blood will be sampled at multiple timepoints during multiple hemodialysis sessions




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007603


Locations
Layout table for location information
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Florian Thalhammer, Prof. MD Medical University of Vienna

Layout table for additonal information
Responsible Party: Florian Thalhammer, a.o.Univ.-Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02007603     History of Changes
Other Study ID Numbers: AMPISUL/AMOXICLAV-HD_V1.4
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Florian Thalhammer, Medical University of Vienna:
chronic hemodialysis
ampicillin
sulbactam
amoxicillin
clavulanic acid
pharmacokinetics

Additional relevant MeSH terms:
Layout table for MeSH terms
Ampicillin
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Sulbactam
Sultamicillin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors