POPPET Study - Measuring the concentration of Piperacillin/Tazobactam, an antibiotic, given over 24 hours as a continuous infusion to children.
- Conditions
- Febrile NeutropeniaMedDRA version: 20.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002644-14-GB
- Lead Sponsor
- Alder Hey Children's NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 15
1.Have an oncology/haematology diagnosis.
2.2 years and upwards.
3.Commenced on Piperacillin/Tazobactam as part of normal standard of care for the treatment of febrile neutropenia.
4.Administration of Piperacillin/Tazobactam is via elastomeric pump.
5.Have a central line with at least 1 lumen that bleeds back for sampling.
6.Written informed consent from parent/legal guardian if patient <16 years or from patient if =16 years. This person must understand the contents of the consent, requirements of the study and have had an opportunity to review questions with a medically trained member of the site study team.
7.Written assent from older competent patients (judged on a case by case basis).
8.Patient and parent/legal guardian must have a good understanding of the English language, in which the consent/assent forms are available, and understand the requirements for reporting of any AE to the Investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1.Age less than 2 years.
2.Central line that doesn’t bleed back.
3.A patient where treatment with Piperacillin/Tazobactam is not considered first line e.g. patient with known bacterial resistance.
4.Written consent not obtained.
5.An older competent participant (judged on case by case basis) declines assent to study.
6.The patient is deemed unsuitable at the discretion of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): To measure the serum concentration at set time points for Piperacillin/Tazobactam when delivered by elastomeric pump in stated population.;Main Objective: What plasma concentrations are achieved in continuous infusion administration of Piperacillin/Tazobactam via elastomeric device in paediatric patients being treated for febrile neutropenia?;Secondary Objective: Are there any adverse effects of administration of Piperacillin/Tazobactam via elastomeric pump?;Timepoint(s) of evaluation of this end point: Pharmacokinetic bloods will be taken at 0.5, 2 and 4 hours post intermittent dose of Piperacillin/Tazobactam, prior to starting the continuous infusion, and at 3 time points during an elastomeric pump (at least 3 hours apart). The bloods will be batched and sent for analysis after the first 5 patients and at completion of all study sample collection. <br><br>Blood samples will be frozen and analysed as a batch within 3 months of the end of the study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Are there any adverse effects of administration of Piperacillin/Tazobactam using an elastomeric pump?;Timepoint(s) of evaluation of this end point: This will be assessed as part of the ongoing study procedures.