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

Prospective, randomized, multicenter clinical trial on the impact of Therapeutic Drug Monitoring (TDM) of piperacillin on organ functions and survival in the treatment of severe sepsis or septic shock - Target

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000136-17-DE

Enrollment

276

Registered

2016-04-08

Start date

2016-08-22

Completion date

Unknown

Last updated

2020-03-18

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

Conditions

Patients with a severe sepsis oder a septic shock treatet with piperacillin/tazobactam

Interventions

Product Name: Piperacillin/Tazobactam Product Code: Pip/Taz Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Piperacillin CAS Number: 59703-84-3 Other descriptive name: PIPER

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: As the primary goal of the study, it needs to be established whether an optimisation of antimicrobial therapy by individual dose adjustment of the test substance Piperacillin has a beneficial impact on organ function in severe sepsis or septic shock and whether it is superiour to dosage following prescribing information. This should be examined on the basis of global morbidity measurement (mean total SOFA-score). ;Secondary Objective: • SOFA-Subscores Impact of intervention on • 28-day mortality • duration and cumulative dose of antibiotic therapy • number of dose adjustment/treatment cycle • days without antibiotics • time spent on intensive care unit • time spent in hospital • days without vasopressors • days without renal replacement therapy • days without mechanical ventilation • safety (side effects) • antibiotic therapy costs ;Primary end point(s): mean total SOFA-Score – from 1st day after randomization until ICU-discharge or dead, but only until 10th day after randomisation ;Timepoint(s) of evaluation of this end point: daily from randomisation day until 10th day after randomisation	—

Measure

Time frame

Main Objective: As the primary goal of the study, it needs to be established whether an optimisation of antimicrobial therapy by individual dose adjustment of the test substance Piperacillin has a beneficial impact on organ function in severe sepsis or septic shock and whether it is superiour to dosage following prescribing information. This should be examined on the basis of global morbidity measurement (mean total SOFA-score). ;Secondary Objective: • SOFA-Subscores Impact of intervention on • 28-day mortality • duration and cumulative dose of antibiotic therapy • number of dose adjustment/treatment cycle • days without antibiotics • time spent on intensive care unit • time spent in hospital • days without vasopressors • days without renal replacement therapy • days without mechanical ventilation • safety (side effects) • antibiotic therapy costs ;Primary end point(s): mean total SOFA-Score – from 1st day after randomization until ICU-discharge or dead, but only until 10th day after randomisation ;Timepoint(s) of evaluation of this end point: daily from randomisation day until 10th day after randomisation

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Secondary

Measure	Time frame
Secondary end point(s): • SOFA-Subscores • 28-day mortality • duration and cumulative dosage of antibiotic therapy • number of dose adjustment / therapy cycle • days without antibiotic, maximum day 14 • Length of ICU stay, maximum day 28 • Length of hospital stay, maximum day 28 • days without vasopressor, maximum day 14 • days without renal replacement therapy until day 28 • days without mechanical ventilation until day 28 • safety (side effects) • antibiotic therapy costs ;Timepoint(s) of evaluation of this end point: during the overall study period and day 28, respectively	—

Measure

Time frame

Secondary end point(s): • SOFA-Subscores • 28-day mortality • duration and cumulative dosage of antibiotic therapy • number of dose adjustment / therapy cycle • days without antibiotic, maximum day 14 • Length of ICU stay, maximum day 28 • Length of hospital stay, maximum day 28 • days without vasopressor, maximum day 14 • days without renal replacement therapy until day 28 • days without mechanical ventilation until day 28 • safety (side effects) • antibiotic therapy costs ;Timepoint(s) of evaluation of this end point: during the overall study period and day 28, respectively

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Countries

Germany

Contacts

Public ContactProject Manager

Jena University Hospital, Center for Clinical Studies

ZKS-Projektmanagement@med.uni-jena.de+4936419396620

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 2, 2026