Concentration of ampicillin / sulbactam and amoxicillin / clavulanic acid in the blood during renal replacement therapy in longterm renal replacent therapy patients

Multiple-dose pharmacokinetics of ampicillin / sulbactam and amoxicillin / clavulanic acid during haemodialysis in longterm haemodialysis patients - AMPISUL/AMOXICLAV-HD_V1.4

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001496-36-AT

Enrollment

Registered

2013-06-25

Start date

2013-07-19

Completion date

Unknown

Last updated

2018-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected or proven bacterial infection requiring therapy with broad spectrum antibiotics MedDRA version: 14.1 Level: LLT Classification code 10042196 Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10053021 Term: Gram-positive bacterial infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification

Interventions

Trade Name: Unasyn Product Name: Unasyn Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Ampicillin CAS Number: 69-53-4 Other descriptive name: AMPICILLIN Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Age >18 years b) Suspected or proven bacterial infection requiring parenteral antibiotic therapy. c) Organ replacement therapy (HD) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: a) Known hypersensitivity to ampicillin / sulbactam, amoxicillin / clavulanic acid or other beta-lactames, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents. b) An expected survival of less than two days. c) Known pregnancy d) Co-administration of one of the following drugs: - probenecid which cannot be discontinued for the duration of the study e) Ampicillin / sulbactam respectively amoxicillin / clavulanic acid as monotherapy for resistant species or fungal infections. f) Other reasons opposing the study participation on the discretion of the investigators.

Design outcomes

Primary

Measure	Time frame
Main Objective: Measuring pharmakokinetecs of ampicillin / sulbactam and amoxicillin / clavulanic acid during haemodialysis;Secondary Objective: Comparison of development of liver enzyme serum levels during therapy with both drug combinations;Primary end point(s): Pharmacokinetics of ampicillin / sulbactam and amoxicillin / clavulanic acid in haemodialysis: area under the curve (AUC), half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction.;Timepoint(s) of evaluation of this end point: 0, 0.5, 1, 2, 3.5 and 4 hours post infusion on day hemodialysis day 2 (HD2), and 0, 0.5 and 1 hour post infusion on HD3 to 7	—

Measure

Time frame

Main Objective: Measuring pharmakokinetecs of ampicillin / sulbactam and amoxicillin / clavulanic acid during haemodialysis;Secondary Objective: Comparison of development of liver enzyme serum levels during therapy with both drug combinations;Primary end point(s): Pharmacokinetics of ampicillin / sulbactam and amoxicillin / clavulanic acid in haemodialysis: area under the curve (AUC), half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction.;Timepoint(s) of evaluation of this end point: 0, 0.5, 1, 2, 3.5 and 4 hours post infusion on day hemodialysis day 2 (HD2), and 0, 0.5 and 1 hour post infusion on HD3 to 7

—

Secondary

Measure	Time frame
Secondary end point(s): elevation of liver enzymes (gamma-GT, ASAT, ALAT, aP) under both therapies;Timepoint(s) of evaluation of this end point: Hemodialysis day 2 to 7	—

Countries

Austria

Contacts

Public ContactFlorian Thalhammer

Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische abteilung für Infektionen und Tropenme

florian.thalhammer@meduniwien.ac.at00431404004440

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026