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

Infection During Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007603
• Other study ID #: AMPISUL/AMOXICLAV-HD_V1.4
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2013
• Last updated: May 29, 2017
• Start date: August 2013
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2017
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection During Hemodialysis

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of hemodialysis on the area under concentration curve of ampicillin/sulbactam and amoxicillin / clavulanic acid plasma concentration levels.	Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation.	day 15