Therapeutic drug Monitoring (TDM) of piperacillin in patients with fever in neutropenia in the course of myelosuppressive cytostatic chemotherapy

Phase 4

• Conditions: B99; Other and unspecified infectious diseases

• Registration Number: DRKS00011023
• Lead Sponsor: niversitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-02
• Study Completion: 2018-06-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

•Fever (defined as 1 episode >38,3°C or 2 episodes >38,0°C within 2 hours) in neutropenia (defined as WBC < 1 Gpt/l or neutrophile granulocytes <0,5Gpt/l) following myelosuppressive chemotherapy
•imminent or ongoing therapy with Piperacillin/Tazobactam (Pip/Taz)
•signed informed consent

Exclusion Criteria

•Age < 18 years
•Pregnancy/Breastfeeding
•Women at prolific age without dependable contraception
•Patients unable to consent
•Medical history-documented hypersensitivity toward beta-lactam antibiotics or components of the study drug formulation (Pip/Taz)
•Treatment with Pip/Taz at daily dose >18g within the last 24 hours before randomization
•Participation in another interventional clinical trial
•Prior participation in the current trial (TARGET-FN)
•Impaired liver function (Child-Pugh C)
•Renal failure (eGFR <40ml/min)
•Infectious condition that requires a defined different antibiotic therapy (e.g. endocarditis)
•Life expectancy < 90 days

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Persistent afebrility (yes/no), defined as absence of fever over 5 consecutive days without changes of the antimicrobial therapy. The proportions of afebrile patients in the groups with and without therapeutic drug monitoring will be compared.

Secondary Outcome Measures

Name	Time	Method
•Mortality over 30 days<br>•Infection-related mortality over 30 days<br>•Duration and cumulative dose of antibiotic therapy<br>•Number of dose adjustments per treatment cycle<br>•Duration of combined therapy with anti-infectious agents<br>•Number of in-hospital antibiotic-free days<br>•Necessity of ICU treatment<br>•Duration of in-hospital sojourn <br>•Cost of antibiotic treatment<br>•Pharmakokinetics (PK) / Pharmakodynamics (PD) - Indices (e.g. antibiotic concentration >4x MIC 100% )<br>•Number of antibiotic-free days during neutropenia phase<br>•Infection successfully treated<br>•Progression to SIRS/Sepsis <br>•Occurrence of antibiotic-resistant pathogens<br>•Rate of super-infection with a different pathogen<br>•Safety (untoward effects)