E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
High temperatures in a patient with low white cell counts (and so unable to fight off infections in the usual way - usually due to anti-cancer medication) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016288 |
E.1.2 | Term | Febrile neutropenia |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
What plasma concentrations are achieved in continuous infusion administration of Piperacillin/Tazobactam via elastomeric device in paediatric patients being treated for febrile neutropenia? |
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E.2.2 | Secondary objectives of the trial |
Are there any adverse effects of administration of Piperacillin/Tazobactam via elastomeric pump? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <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. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
To measure the serum concentration at set time points for Piperacillin/Tazobactam when delivered by elastomeric pump in stated population. |
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E.5.1.1 | 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. |
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E.5.2 | Secondary end point(s) |
Are there any adverse effects of administration of Piperacillin/Tazobactam using an elastomeric pump? |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
This will be assessed as part of the ongoing study procedures. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Pharmacokinetic study of different administration of licensed drug i.e. continuous administration |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Completion of analysis of all PK samples. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 28 |