Investigation on how children with cancer and fever metabolise the antibiotic, Piperacillin-tazobactam (PT) for the purpose of optimising the 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 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004281-10-DK

Enrollment

Registered

2017-12-06

Start date

2018-01-10

Completion date

Unknown

Last updated

2020-07-13

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 MedDRA version: 20.0 Level: LLT Classification code 10051312 Term: Neutropenic fever System Organ Class: 100000004851 MedDRA version: 20.0 Level: LLT Classification code 10076734 Term: Chemotherapy induced neutropenia System Organ Class: 100000004851 MedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864

Interventions

Trade Name: Tazocin Product Name: Tazocin: Piperacillin/Tazobactam Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion INN or Proposed INN: Tazobactam Other descript

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Children with cancer and fever who get admitted to the paediatric oncology department and start Tazocin treatment - 6 months - 18 years - All cancer types can be included - A child can participate a maximum of 3 times in case of several fever episodes Are the trial subjects under 18? yes Number of subjects for this age range: 50 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: - Babies that are only breast or bottle feed - Not possible to take blood samples from the child's central venuous catheter - Weight < 8 kg

Design outcomes

Primary

Measure	Time frame
Secondary Objective: We conducted a clinical trial to describe the pharmacokinetics of Tazocin in the present Tazocin bolus regimen in children with cancer and fever (sub-study 2). Our preliminary results show that the children have Tazocin concentrations below the target range in above 50% of the time. The results also indicate that continuous Tazocin infusion would be more optimal. Therefore, in sub-study 3, we want to investigate whether continuous infusion of Tazocin can optimize the antibiotic treatment in this group of children by providing a more stable Tazocin level above MIC.;Primary end point(s): For continuous infusion of Tazocin, our primary endpoint is to investigate if the children 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. We want to determine, if continuous infusion of this drug provides a more stable antibiotic concentration above MIC compared to the current bolus regimen. So, the overall endpoint 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 endpoint is spring/summer 2019. By this time all blood samples should be gathered and analyzed.;Main Objective: The main objective of the PhD study is to optimize the dosing regimen of empiric Tazocin treatment in pediatric oncology patients with fever. In sub-study 3, the main purpose is to determine whether continuous Tazocin infusion provide antibiotic concentrations associated with maximal activity in relation to MIC-levels. Furthermore, we want to find the most optimal dosing schedule.	—

Measure

Time frame

Secondary Objective: We conducted a clinical trial to describe the pharmacokinetics of Tazocin in the present Tazocin bolus regimen in children with cancer and fever (sub-study 2). Our preliminary results show that the children have Tazocin concentrations below the target range in above 50% of the time. The results also indicate that continuous Tazocin infusion would be more optimal. Therefore, in sub-study 3, we want to investigate whether continuous infusion of Tazocin can optimize the antibiotic treatment in this group of children by providing a more stable Tazocin level above MIC.;Primary end point(s): For continuous infusion of Tazocin, our primary endpoint is to investigate if the children 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. We want to determine, if continuous infusion of this drug provides a more stable antibiotic concentration above MIC compared to the current bolus regimen. So, the overall endpoint 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 endpoint is spring/summer 2019. By this time all blood samples should be gathered and analyzed.;Main Objective: The main objective of the PhD study is to optimize the dosing regimen of empiric Tazocin treatment in pediatric oncology patients with fever. In sub-study 3, the main purpose is to determine whether continuous Tazocin infusion provide antibiotic concentrations associated with maximal activity in relation to MIC-levels. Furthermore, we want to find the most optimal dosing schedule.

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Secondary

Measure	Time frame
Secondary end point(s): In sub-study 3, we want to determine if continuous infusion of this drug provides a more stable antibiotic concentration above MIC compared to the current bolus regimen. Furthermore, I det trejde delstudie ønsker vi at undersøge, om kontinuerlig infusion af Tazocin resulterer i en mere optimal antibiotikaprofil i henhold til MIC- værdierne. Vi vil endvidere bestemme hvilken dosis af Tazocin givet som bolus efterfulgt af kontinuerlig infusion, der giver den mest optimale farmakokinetiske profil i relation til MIC værdierne for de patogene mikroorganismer beskrevet i delstudie 1. we will determine the most optimal dosing of Tazocin administered as continous infusion.;Timepoint(s) of evaluation of this end point: Spring/summer 2019	—

Measure

Time frame

Secondary end point(s): In sub-study 3, we want to determine if continuous infusion of this drug provides a more stable antibiotic concentration above MIC compared to the current bolus regimen. Furthermore, I det trejde delstudie ønsker vi at undersøge, om kontinuerlig infusion af Tazocin resulterer i en mere optimal antibiotikaprofil i henhold til MIC- værdierne. Vi vil endvidere bestemme hvilken dosis af Tazocin givet som bolus efterfulgt af kontinuerlig infusion, der giver den mest optimale farmakokinetiske profil i relation til MIC værdierne for de patogene mikroorganismer beskrevet i delstudie 1. we will determine the most optimal dosing of Tazocin administered as continous infusion.;Timepoint(s) of evaluation of this end point: Spring/summer 2019

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Countries

Denmark

Contacts

Public ContactSabine Frølich Maarbjerg

Department of Pediatric Oncology, Aarhus University Hospital, Skejby

sabine.froelich@midt.rm.dk

Outcome results

None listed

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