Status: Ongoing First registered on: 06/11/2014
Last updated on: 19/12/2014
1. Study identification
EU PAS Register NumberEUPAS7901
Official titleEvaluation of a regional information campaign on the appropriate use of antibiotics: a prospective controlled study
Study title acronym
Study typeOther: Non-clinical trial
Brief description of the studyAn information campaign aimed at reducing antibiotic prescribing is going to be implemented in Emilia-Romagna, a region in Northern Italy with about 4,400,000 inhabitants, in December 2014. The campaign messages have been designed to increase awareness of the potential threats of unnecessary use of antibiotics. The active collaboration of doctors and pharmacists is expected to enhance the transfer of the campaign key messages to the general population, eventually reducing people's requests of antibiotic prescribing and influencing prescribers' attitudes as well. Leaflets, posters and (where the facilities exist) a short video will be available in waiting rooms of surgeries, in general practice as well as in hospitals and outpatients clinics, and in pharmacies across all the Emilia-Romagna Region. The primary outcome will be the average prescribing rate of antibiotics (J01C, J01D, J01F, J01M, J01XA codes of the Anatomical Therapeutic Chemical Classification System) to outpatients during the five-month period after the campaign start, expressed as defined daily doses per 1000 inhabitants/day. Changes in the prescribing rate of antibiotics in Emilia-Romagna (vs the same period of the previous year) will be assessed and compared to prescribing changes in the rest of Italy and in groups of regions defined by quartiles of prescription rates, taking the possible implementation of specific policies on antibiotics in other regions into account.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 to which the investigator belongsASSR Emilia-Romagna
Department/Research groupInfectious Risk Area
Organisation/affiliationEmilia-Romagna Health and Social Agency
Website/Homepagehttp://asr.regione.emilia-romagna.it/
Details of (Primary) lead investigator
Title Dr
Last name Moro
First name Maria Luisa
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/09/201401/09/2014
Start date of data collection01/12/201401/12/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report30/06/2016
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 bodyASSR Emilia-Romagna100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Moro
First name Maria Luisa
Address line 1Viale Aldo Moro 21
Address line 2 
Address line 3 
CityBologna 
Postcode40127 
CountryItaly
Phone number (incl. country code)390515277139 
Alternative phone number 
Fax number (incl. country code) 
Email address mlmoro@regione.emilia-romagna.it
Public Enquiries
Title Dr 
Last name Moro 
First name Maria Luisa 
Address line 1Viale Aldo Moro 21 
Address line 2 
Address line 3 
CityBologna 
Postcode40127 
CountryItaly 
Phone number (incl. country code)390515277139 
Alternative phone number 
Fax number (incl. country code) 
Email address mlmoro@regione.emilia-romagna.it 
Top