Therapeutic drug monitoring-based dose optimisation of piperacillin in patients with severe sepsis or septic shock to investigate effects on organ functions and survival: a prospective, multicenter, randomized controlled trial

Phase 3

• Conditions: R65.1; R57.2; Systemic Inflammatory Response Syndrome of infectious origin with organ failure; Septic shock

• Registration Number: DRKS00011159
• Lead Sponsor: Friedrich-Schiller-Universität Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-10
• Study Completion: 2020-12-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 254

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

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It should be investigated whether TDM-based piperacillin therapy results in a benefit regarding patient`s organ function. <br><br>primary Endpoint: mean total SOFA (Sequential Organ Failure Assessment) Score – from 1st day after randomization until ICU discharge or death, but only until day 10 after randomization

Secondary Outcome Measures

Name	Time	Method
• SOFA-Subscores<br>• 28-day mortality<br>• duration and cumulative dosage of antibiotic therapy<br>• number of dose adjustment / therapy cycle<br>• days without antibiotic, maximum day 14<br>• Length of ICU stay, maximum day 28<br>• Length of hospital stay, maximum day 28<br>• days without vasopressor, maximum day 14<br>• days without renal replacement therapy until day 28<br>• days without mechanical ventilation until day 28<br>• safety (side effects)<br>• antibiotic therapy costs