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

Phase 1

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10053021Term: Gram-positive bacterial infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: HLTClassification code 10004047Term: Bacterial infections NECSystem Organ Class: 10021881 - Infections and infestations; Suspected or proven bacterial infection requiring therapy with broad spectrum antibiotics; MedDRA version: 14.1Level: LLTClassification code 10035649Term: Pneumococcal secondary bacterial infection of acute bronchitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 14.1Level: LLTClassification code 10004038Term: Bacterial infection due to streptococcus, group CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10042196Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10054278Term: Bacterial infection due to streptococcus, group FSys; MedDRA version: 16.0Level: LLTClassification code 10004031Term: Bacterial infection due to other gram-negative organismsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10004039Term: Bacterial infection due to streptococcus, group DSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2012-001496-36-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische abteilung für Infektionen und Tropenme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-25
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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