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

Phase 1

Conditions: Pediatric oncology patients with fever and neutropenia
MedDRA version: 18.1Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-000466-33-DK

Lead Sponsor: Department of Pediatric oncology, Aarhus University hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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