Measurement of the blood concentration of the antibiotic piperacillin and individual drug dosage in patients having a severe sepsis oder a septic shock

Phase 1

• Conditions: Patients with a severe sepsis oder a septic shock treatet with piperacillin/tazobactam; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-000136-17-DE
• Lead Sponsor: Friedrich Schiller University Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-08
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

•Patients with severe sepsis or septic shock
•onset of severe sepsis or septic shock not longer than 24 hours prior to randomization
•Antimicrobial therapy with piperacillin planned or started
•age =18 years
•written informed consent of the patient or legal representative

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 176
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•pregnant or breast-feeding women
•anamnestic known hypersensitivity against beta-lactam antibiotics or another part of the investigational medicinal product
•previous treatment with piperacillin (in combination with tazobactam) > 24 hours before randomization
•participation in another interventional clinical trial
•previous participation (TARGET)
•limits of therapy or cessation
•impaired liver function (Child-Pugh C)
•life expectancy < 28 day due to accompanying illnesses
•piperacillin-measurement impossible within 24 hours after randomization

Study & Design

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