E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pediatric oncology patients with fever and neutropenia |
Børn med cancer og febril neutropeni |
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E.1.1.1 | Medical condition in easily understood language |
Children with cancer and fever |
Børn med kræft og feber |
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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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007050 |
E.1.2 | Term | Cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Det overordnede formål med vores projekt er at optimere dosis og indgiftsmetode for den empiriske Tazocin-behandling til børneonkologiske patienter ud fra farmakokinetiske og – dynamiske studier af Tazocin hos denne gruppe børn. |
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E.2.2 | Secondary objectives of the trial |
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. |
Formålet er at analysere, om nuværende behandlingsregime med bolusinjektion af Tazocin 100 mg/kg hver 8. time er forbundet med en hensigtsmæssig farmakokinetisk profil af stoffet i henhold til MiC-niveauerne. Desuden ønsker vi at analysere intrapatient variationen af PTs farmakokinetiske parametre og udfærdige en farmakokinetisk model. Samtidig vil vi relatere resultaterne af ovenstående til følgende parametre hos barnet: alder, vægt, overfladeareal, leukocyt- og neutrofiltal, nyrefunktion (glomerulær filtration (GFR) målt ved Schwartz’ formel), tilstedeværende bakteriæmi/sepsis, anden konkomitant antibiotikabehandling og se-albumin. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: "Determination of Minimal Inhibitory Concentration (MIC) of Tazocin in the most pathogenic bacteria in pediatric oncology patients" Version 3, 02-19-2016
Objective of the sub-study: Determination of MIC-levels of the most pathogenic bacteria in blood cultures from children with cancer and febrile neutropenia who have been admitted to the department of Pediatric Oncology, Aarhus University Hospital. |
Titel: "Minimal Inhibitorisk Concentration (MIC) for isolater af patogene bakteriestammer dyrket fra blodet hos børn med cancer", version 3, 2016.02.19
Formålet med første delstudie er bestemmelse af MIC-niveauer for de mest patogene bakteriestammer, der er dyrket fra blodet hos børn med cancer og febril neutropeni. På baggrund af MIC-værdierne vil vi undersøge, hvilken koncentration af Tazocin i blodet, man skal stile mod for at opnå maksimal effekt af stoffet hos børn i behandling med empirisk Tazocin. |
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E.3 | Principal 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 |
-Børn med cancer, som bliver indlagt på Børneonkologisk afdeling, A20, AUH med kemoinduceret febril neutropeni og opstartes i empirisk antibiotikabehandling med Tazocin. - Alderskriterium: ½ – 18 år - Inklusion uafhængigt af underliggende cancerform - Hvert barn kan indgå flere gange i forbindelse med hver antibiotikabehandlingsperiode og kan indgå selvom barnet får anden type antibiotika samtidigt.
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E.4 | Principal 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
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- Småbørn, der ammes fuldt - Børn, der ikke har CVK eller anden central adgang - Børn, hvor det ikke er praktisk muligt at tage blodprøver fra CVK |
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E.5 End points |
E.5.1 | 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. |
Dvs. at vores outcome i dette studie er at undersøge, hvor stor en andel af børnene, der opnår Tazocin koncentrationer > 4 x MIC for de mikroorganismer, der er beskrevet i delstudie 1 i > 50% af doseringsintervallet eller > 1 x MIC i 100 % af doseringsintervallet |
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E.5.1.1 | 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. |
Data forventes indsamlet og analyseret, herunder udarbejdelse af en farmakokinetisk model, januar-februar 2018. |
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E.5.2 | 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. |
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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
October 2018 |
Oktober 2018 |
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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 | Yes |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Deskriptivt og prospektivt studie |
Descriptive + prosepctive study |
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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 | Yes |
E.8.2.3.1 | Comparator description |
farmakokinetik og farmakodynamik af Tazocin hos børneonkologiske patienter |
We investigate tha pharmacokinetics and pharmacodynamics of Tazocin in pediatric oncology patients |
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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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LVLS |
Sidste besøg/indlæggelse for sidste patient afslutter forsøget. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |