Investigation on how children with cancer and fever metabolise the antibiotic, Piperacillin-tazobactam (PT) to help optimize antibiotic treatment in this group of patients.

Pharmacokinetics and pharmacodynamics of Piperacillin-Tazobactam (PT) in pediatric oncology patients with fever and neutropenia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000466-33-DK

Enrollment

100

Registered

2016-03-01

Start date

2016-03-22

Completion date

Unknown

Last updated

2018-03-12

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

Conditions

Pediatric oncology patients with fever and neutropenia MedDRA version: 18.1 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864

Interventions

Trade Name: Tazocin Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Children aged 6 months - 18 years with cancer and febrile neutropenia during chemotherapy who starts empiric Tazocin treatment - Admission to the department of pediatric oncology A20, Aarhus University hospital - independent of cancer type - Each child can participate every more than one time if he/she has several episodes of fever during chemotherapy - Has CVK or other central venous catheter Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Children that are solely breastfeed - Children who do not have a central venous catheter or another central catheter (CVK) - Children were it is not possible to draw blood from the CVK

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this trial is to optimize the dosing and interval regimen of empiric Tazocin treatment in pediatric oncology patients with fever and neutropenia. ;Secondary Objective: To describe the pharmacokinetics of Tazocin in children with cancer and FN. We want to determine whether Tazocin dosing with bolus injection achieves concentrations associated with maximal activity in relation to MIC-levels. ;Primary end point(s): Our primary outcome or endpoint is to investigate if the children in the study group reach Tazocin levels > 4 x MIC for the most pathogenic bacteria in > 50% of the dosing interval or > 1 x MIC i 100 % of the dosing interval. The overall goal is to optimize the Tazocin treatment in this group of children. ;Timepoint(s) of evaluation of this end point: The timepoint of evaluation of this end point is jan-feb. 2018. By this time all blood samples should be gathered and analyzed.	—

Measure

Time frame

Main Objective: The main objective of this trial is to optimize the dosing and interval regimen of empiric Tazocin treatment in pediatric oncology patients with fever and neutropenia. ;Secondary Objective: To describe the pharmacokinetics of Tazocin in children with cancer and FN. We want to determine whether Tazocin dosing with bolus injection achieves concentrations associated with maximal activity in relation to MIC-levels. ;Primary end point(s): Our primary outcome or endpoint is to investigate if the children in the study group reach Tazocin levels > 4 x MIC for the most pathogenic bacteria in > 50% of the dosing interval or > 1 x MIC i 100 % of the dosing interval. The overall goal is to optimize the Tazocin treatment in this group of children. ;Timepoint(s) of evaluation of this end point: The timepoint of evaluation of this end point is jan-feb. 2018. By this time all blood samples should be gathered and analyzed.

—

Secondary

Measure	Time frame
Secondary end point(s): In the third sub-study we aim to investigate whether continuous Tazocin infusion is associated with prolonged time of PT concentration above MIC. Furthermore we will determine the most optimal dosing of Tazocin administered as continous infusion. ;Timepoint(s) of evaluation of this end point: October 2018	—

Countries

Denmark

Contacts

Public ContactSabine Frølich Maarbjerg

Department of Pediatrics, Aarhus University Hospital, Skejby

sabine.froelich@midt.rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026