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

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Infection During Hemodialysis

Treatments: Procedure: Blooddraws for pharmacokinetic profiling; Drug: Administration of Amoxicillin / clavulanic acid; Drug: Ampicillin / sulbactam

Study type: Interventional

Funder types: Other

Identifiers

NCT02007603

AMPISUL/AMOXICLAV-HD_V1.4

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Ampicillin / sulbactam

Experimental group

Description:

Patients are randomized to the ampicillin / sulbactam arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.

Treatment:

Procedure: Blooddraws for pharmacokinetic profiling

Drug: Ampicillin / sulbactam

Amoxicillin / clavulanic acid

Experimental group

Description:

Patients are randomized to the amoxicillin / clavulanic acid arm. Pharmacokinetic samples will be taken during multiple hemodialysis sessions.

Treatment:

Drug: Administration of Amoxicillin / clavulanic acid

Procedure: Blooddraws for pharmacokinetic profiling