Upper Respiratory Tract InfectionsPhase 2LOCAALNCT01604096
Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy
A Phase 2 study testing Multifaceted information campaign in people with Upper Respiratory Tract Infections, run by Regional Health and Social Care Agency, Italy at 2 sites in Italy.
Trial summary
Use of information campaigns and educational interventions directed to citizens and supported by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by several studies with conflicting results. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- Multifaceted information campaign
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesItaly
- Study dates
- Nov 2011to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- the campaign has been targeted at the general population in the intervention areas
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Local Health Authority of Modena
Modena, 41100
Local Health Authority of Parma
Parma, 43100
About this study
Official title: Doctors and Local Media: a Synergy for Public Health Information? A Controlled Trial to Evaluate the Effects of a Multifaceted Campaign on Antibiotic Prescribing
Use of information campaigns and educational interventions directed to citizens and supported by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by several studies with conflicting results. These interventions are potentially relevant, favouring the reduction of unnecessary use of medicines and related risks. Several studies have specifically evaluated the promotion of the appropriate use of antibiotics in adults and children, with variable results. A controlled study has been proposed to evaluate the feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic prescription by increasing awareness on risks of their unnecessary use.
Information has been provided to citizens through several media (posters, local TV, radio and newspapers, video terminals, websites of Local Health Authorities). Brochures with information on expected benefits and risks of antibiotics has also been available, either with direct access in waiting rooms and pharmacies or handed out and mediated by doctors. Physicians and pharmacists received specific data on local antibiotic resistance. A small group of representative doctors have also actively participated in defining the campaign key messages. A sample of general practitioners and paediatricians have been trained in patient counselling strategies.
Read more
The information campaign has been implemented in two Provinces of Emilia-Romagna during the fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be compared versus other areas in the same Region. Knowledge and attitudes of the general population will be evaluated through a phone and internet survey on a representative sample.
This study could observe a reduction lower than 5% in the prescribing rate of antibiotics.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- Multifaceted information campaign
- Keywords
- Information, campaign, antibiotics, bacterial resistance, primary care
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted information campaignOther
Following is the description of the multifaceted intervention:
- brochures targeted at the general population and available in general practices, pharmacies, local health services and on the web (also translated in eight languages)
- posters (same distribution as brochures)
- short videos transmitted in local TVs, websites of Local Health Authorities and in video terminals in some pharmacies
- radio-spots transmitted in local radio stations
- advertisements in local newspapers
- banners on websites of local newspapers
- newsletter on antibiotic resistance in Emilia- Romagna, available to physicians and pharmacists
- training courses in counselling strategies, directed to a subgroup of GPs and paediatricians
| Study group | Role | What they receive |
|---|---|---|
| Intervention areas | Experimental | Provinces of Modena and Parma (about 1.100.000 inhabitants - campaign targeted to the general population), in Northern Italy (Emilia-Romagna Region) Receives: Other: Multifaceted information campaign |
| Control | No intervention | All the other provinces in the Emilia-Romagna Region (where the information campaign has not been implemented) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescribing rate of antibiotics
Cumulative five-month changes in DDD per 1000 inhabitants/day of specific classes of antibiotics (J01C, J01D, J01F, J01M ATC codes) in general practice
Measured: up to 03/12
Secondary outcomes (3)
Antibiotic prescribing trends
Changes in antibiotic prescribing trends in eighteen months (same ATCs as for primary outcome)
Measured: up to 04/13
Antibiotic expenditure
Changes in antibiotic expenditure per 1000 inhabitants/day (same ATCs as for primary outcome)
Measured: up to 03/12
Knowledge/attitudes of the general population
Knowledge of and attitudes about the campaign messages, through a telephone and internet survey on a sample of the target population.
Measured: up to 02/12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Regional Health and Social Care Agency, Italy
- Sponsor type
- Other government
- Collaborators
- Local Health Authority, Parma, Local Health Authority, Modena, Change Institute, Turin
- Responsible party
- Sponsor
- Investigators
- Giulio Formoso, MPH, MPharm, Principal investigator, Regional Health and Social Care Agency, Emilia Romagna Region (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604096
- Sponsor's protocol ID
- FARM8FKC3H
- Acronym
- LOCAAL
- Status last verified
- May 2012
- First submitted
- 17 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
LOcal Campaign on Antibiotics ALliance (LOCAAL) study group. Doctors and local media: a synergy for public health information?: a controlled trial to evaluate the effects of a multifaceted campaign on antibiotic prescribing (protocol). BMC Public Health. 2011 Oct 19;11:816. doi: 10.1186/1471-2458-11-816.
PubMed 22011332Formoso G, Paltrinieri B, Marata AM, Gagliotti C, Pan A, Moro ML, Capelli O, Magrini N; LOCAAL Study Group. Feasibility and effectiveness of a low cost campaign on antibiotic prescribing in Italy: community level, controlled, non-randomised trial. BMJ. 2013 Sep 12;347:f5391. doi: 10.1136/bmj.f5391.
PubMed 24030722
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doctors and Local Media: a Synergy for Public Health Information? A Controlled Trial to Evaluate the Effects of a Multifaceted Campaign on Antibiotic Prescribing
- ClinicalTrials.gov ID
- NCT01604096
- Acronym / sponsor ID
- LOCAAL / FARM8FKC3H
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- Information, campaign, antibiotics, bacterial resistance, primary care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Regional Health and Social Care Agency, ItalyOther government
- Collaborators
- Local Health Authority, Parma, Local Health Authority, Modena, Change Institute, Turin
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of information campaigns and educational interventions directed to citizens and supported by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by several studies with conflicting results. These interventions are potentially relevant, favouring the reduction of unnecessary use of medicines and related risks. Several studies have specifically evaluated the promotion of the appropriate use of antibiotics in adults and children, with variable results. A controlled study has been proposed to evaluate the feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic prescription by increasing awareness on risks of their unnecessary use.
Information has been provided to citizens through several media (posters, local TV, radio and newspapers, video terminals, websites of Local Health Authorities). Brochures with information on expected benefits and risks of antibiotics has also been available, either with direct access in waiting rooms and pharmacies or handed out and mediated by doctors. Physicians and pharmacists received specific data on local antibiotic resistance. A small group of representative doctors have also actively participated in defining the campaign key messages. A sample of general practitioners and paediatricians have been trained in patient counselling strategies.
The information campaign has been implemented in two Provinces of Emilia-Romagna during the fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be compared versus other areas in the same Region. Knowledge and attitudes of the general population will be evaluated through a phone and internet survey on a representative sample.
This study could observe a reduction lower than 5% in the prescribing rate of antibiotics.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention areas | Experimental | Other: Multifaceted information campaignProvinces of Modena and Parma (about 1.100.000 inhabitants - campaign targeted to the general population), in Northern Italy (Emilia-Romagna Region) |
| Control | No intervention | –All the other provinces in the Emilia-Romagna Region (where the information campaign has not been implemented) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the campaign has been targeted at the general population in the intervention areas
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted information campaignFollowing is the description of the multifaceted intervention: * brochures targeted at the general population and available in general practices, pharmacies, local health services and on the web (also translated in eight languages) * posters (same distribution as brochures) * short videos transmitted in local TVs, websites of Local Health Authorities and in video terminals in some pharmacies * radio-spots transmitted in local radio stations * advertisements in local newspapers * banners on websites of local newspapers * newsletter on antibiotic resistance in Emilia- Romagna, available to physicians and pharmacists * training courses in counselling strategies, directed to a subgroup of GPs and paediatricians | Other | Intervention areas |
Primary outcome
Prescribing rate of antibiotics
Time frame: up to 03/12
Cumulative five-month changes in DDD per 1000 inhabitants/day of specific classes of antibiotics (J01C, J01D, J01F, J01M ATC codes) in general practice
3 secondary outcomes
Antibiotic prescribing trends
Time frame: up to 04/13
Antibiotic expenditure
Time frame: up to 03/12
Knowledge/attitudes of the general population
Time frame: up to 02/12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Background: PubMed 22011332LOcal Campaign on Antibiotics ALliance (LOCAAL) study group. Doctors and local media: a synergy for public health information?: a controlled trial to evaluate the effects of a multifaceted campaign on antibiotic prescribing (protocol). BMC Public Health. 2011 Oct 19;11:816. doi: 10.1186/1471-2458-11-816.
- Derived from this study: PubMed 24030722Formoso G, Paltrinieri B, Marata AM, Gagliotti C, Pan A, Moro ML, Capelli O, Magrini N; LOCAAL Study Group. Feasibility and effectiveness of a low cost campaign on antibiotic prescribing in Italy: community level, controlled, non-randomised trial. BMJ. 2013 Sep 12;347:f5391. doi: 10.1136/bmj.f5391.
- Published protocolLink provided by the sponsor.
- Campaign home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulio Formoso, MPH, MPharm principal investigator
Regional Health and Social Care Agency, Emilia Romagna Region (Italy)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multifaceted information campaign in people with Upper Respiratory Tract Infections, run by Regional Health and Social Care Agency, Italy at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescribing rate of antibiotics (time frame: up to 03/12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01604096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.