POPPET Study - Measuring the concentration of Piperacillin/Tazobactam, an antibiotic, given over 24 hours as a continuous infusion to children.

POPPET Study - Pharmacokinetics of continuous administration of Piperacillin/Tazobactam to children using an elastomeric pump - POPPET Study (PK of continuous infusion of Pip/Taz in children)

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002644-14-GB

Enrollment

Registered

2015-08-03

Start date

2015-09-15

Completion date

Unknown

Last updated

2019-01-07

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

Conditions

Febrile Neutropenia MedDRA version: 20.0 Level: PT Classification code 10016288 Term: Febrile neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Product Name: Piperacillin/Tazobactam Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Piperacillin/Tazobactam

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. Blood samples will be frozen and analysed as a batch within 3 months of the end of the study.	—

Measure

Time frame

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. Blood samples will be frozen and analysed as a batch within 3 months of the end of the study.

—

Secondary

Measure	Time frame
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.	—

Countries

United Kingdom

Contacts

Public ContactLucy Cooper

Alder Hey Children's NHS Foundation Trust

lucy.cooper@alderhey.nhs.uk0151 252 5570

Outcome results

None listed

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