Status: Ongoing First registered on: 15/06/2018
Last updated on: 31/01/2019
1. Study identification
EU PAS Register NumberEUPAS24458
Official titleEMIF Use Case 17 - Investigating the relationship in paediatric population between dosing of antibiotics (prescribed, dispensed or administered) and patient’s weight.
Study title acronymEMIF UC17
Study typeObservational study
Brief description of the studyDosing errors are one of the most common types of medication issues and contribute to the mortality and morbidity within the paediatric population. Paediatric patients are at a higher risk than adults of experiencing such problems because of the need for a dose calculation based on the patient’s age, weight (mg/kg), body surface area (mg/m 2 ), and clinical condition. Antibiotics are the medications most widely prescribed in the paediatric population and one of the drug classes most commonly reported to be involved in paediatric dosing errors. Despite a number of studies conducted about antibiotics usage in different European countries, the appropriateness of antibiotic dosing (prescribed by doctors in primary or secondary care, dispensed by community or hospital pharmacies, or administered in hospital settings) according to the child’s age, weight and height (and other related parameters, as Body Mass Index - BMI, Body Surface Area - BSA) has not yet been investigated. In this study, we would like to assess in European Medical Information Framework (EMIF) Electronic Healthcare Records (EHR) databases (DBs) the relationship between dosing of antibiotics prescribed, administered or dispensed (either for outpatients or inpatient settings) to children (age 0-18 yr), and their weight, age and height.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameSo.Se.Te srl
Centre locationItaly
Details of (Primary) lead investigator
Title Dr
Last name Cantarutti
First name Luigi
Is this study being carried out with the collaboration of a research network?
Yes
EMIF
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

ARS
PHARMO, Netherlands
Pedianet, Italy
SIDIAP, Spain
IPCI, Netherlands
Countries in which this study is being conducted
International study

Italy
Netherlands
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed11/12/201211/12/2012
Start date of data collection15/06/201828/06/2018
Start date of data analysis03/12/201803/12/2018
Date of interim report, if expected
Date of final study report31/07/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEU/EFPIA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Tramontan
First name Lara
Address line 1Viale Oberdan 5
Address line 2 
Address line 3 
CityTreviso 
Postcode 
CountryItaly
Phone number (incl. country code)39-3346588058 
Alternative phone number 
Fax number (incl. country code) 
Email address ltramontan@consorzioarsenal.it
Public Enquiries
Title Dr 
Last name Giaquinto 
First name Carlo 
Address line 1Corso Stati Uniti 4 
Address line 2 
Address line 3 
CityPadova 
Postcode 
CountryItaly 
Phone number (incl. country code)39-0498215447 
Alternative phone number 
Fax number (incl. country code) 
Email address carlo.giaquinto@unipd.it 
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