Respiratory Tract InfectionsSAPINCT01358916
Intervention Study to Improve Antibiotic Prescription in Outpatient Care
A study testing Mailing of antibiotic therapy guidelines to the sentinel physicians in people with Respiratory Tract Infections and Urinary Tract Infections, run by University of Bern at 1 site in Switzerland.
Trial summary
Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a major driving force for the development of resistance. Thus optimization of antibiotic prescription and reduction of unnecessary antimicrobial treatment are essential in the prevention and reduction of antimicrobial resistance… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Tract Infections, Urinary Tract Infections
- What is being tested?
- Mailing of antibiotic therapy guidelines to the sentinel physicians
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2010to Dec 2012
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with respiratory tract infections or urinary tract infections
Who cannot join
- Patients with chronic disease requiring regular antibiotic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement of Antibiotic Prescription in Outpatient Care: a Cluster-randomised Intervention Study Using a Sentinel Surveillance Network of Physicians
Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a major driving force for the development of resistance. Thus optimization of antibiotic prescription and reduction of unnecessary antimicrobial treatment are essential in the prevention and reduction of antimicrobial resistance rates.
The goal of this study is the improvement of antibiotic prescription in outpatient care. The study will take place within a Swiss-wide sentinel surveillance network of physicians. The participating physicians will be randomised in a control and intervention group. The intervention group will receive therapeutic guidelines for the treatment of upper and lower respiratory tract infections and lower urinary tract infection as well as regular feed-backs on the prescription pattern of the sentinel physicians during the past months. Sentinel physicians will collect information about each antibiotic prescription, its indication and characteristics of the patient.
Our hypothesis is that the prescription pattern in the intervention group will be optimised and unnecessary antibiotic therapy will be reduced compared to the control group.
Read the detailed description
Background
Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a major driving force for the development of resistance. Thus optimization of antibiotic prescription and reduction of unnecessary antimicrobial treatment are essential in the prevention and reduction of antimicrobial resistance rates.
The goal of this study is the qualitative and quantitative improvement of antibiotic prescription in outpatient care. The study will take place within a Swiss-wide sentinel surveillance network consisting of general practitioners, pediatricians and physicians specialized in internal medicine. The participating physicians will be randomised in a control and intervention group. The intervention group will receive therapeutic guidelines for the treatment of upper and lower respiratory tract infections and lower urinary tract infections. Furthermore, regular feed-backs on the prescription pattern of the sentinel physicians in the last months will be provided.
Information about each antibiotic prescription, its indication and the characteristics of the patients will be collected by the sentinel physicians. The standardized reporting of antibiotic prescription by sentinel physicians has been carried out in Switzerland since 2006.
Our hypothesis is that the intervention will affect the antibiotic prescription pattern and that the investigators will observe an optimization of antibiotic prescription and a decrease in the number of antibiotic prescriptions.
Objective
Primary goals:
- Increase of the percentage of penicillin prescriptions for upper and lower respiratory tract infections
- Increase of the percentage of TMP/SMX prescriptions for lower urinary tract infections in adults
Secondary goal:
- Decrease of the percentage of quinolone prescriptions for COPD exacerbations in adults
- Decrease of the number of antibiotic prescriptions for sinusitis and other upper respiratory tract infections
Methods
Prospective cluster-randomised intervention study. The intervention is the mailing of treatment guidelines for upper and lower respiratory tract infections and lower urinary tract infections as well as regular feed-backs on the antibiotic prescription patterns of the sentinel physicians during the past months.
- Being tested
- Mailing of antibiotic therapy guidelines to the sentinel physicians
- Keywords
- antimicrobial resistance, antibiotic prescription, primary health care, cluster-randomized trial
- Medical subject headings
- Respiratory Tract Infections, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailing of antibiotic therapy guidelines to the sentinel physiciansOther
Mailing of antibiotic therapy guidelines to the sentinel physicians and regular feedback on antibiotic prescription
| Study group | Role | What they receive |
|---|---|---|
| Usual information policy | No intervention | No specific intervention |
| Antibiotic therapy guidelines | Other | Not described Receives: Other: Mailing of antibiotic therapy guidelines to the sentinel physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of prescriptions of penicillin for respiratory tract infections
Measured: Two years
Percentage of prescriptions of TMP/SMX for lower urinary tract infections in adults
Measured: Two years
Secondary outcomes (2)
Percentage of prescriptions of quinolone for COPD exacerbations in adults
Measured: Two years
Percentage of antibiotic prescriptions for the indications "sinusitis" and "other upper respiratory tract infections"
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bundesamt für Gesundheit, Sentinella Netzwerk, Schweizerische Gesellschaft für Infektiologie, Pädiatrische Infektiologie Gruppe Schweiz
- Responsible party
- Sponsor
- Investigators
- Andreas Kronenberg, Dr. med., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358916
- Sponsor's protocol ID
- Swiss Federal Office of Health
- Acronym
- SAPI
- Status last verified
- Mar 2013
- First submitted
- 19 May 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hurlimann D, Limacher A, Schabel M, Zanetti G, Berger C, Muhlemann K, Kronenberg A; Swiss Sentinel Working Group. Improvement of antibiotic prescription in outpatient care: a cluster-randomized intervention study using a sentinel surveillance network of physicians. J Antimicrob Chemother. 2015 Feb;70(2):602-8. doi: 10.1093/jac/dku394. Epub 2014 Oct 17.
PubMed 25326088
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Antibiotic Prescription in Outpatient Care: a Cluster-randomised Intervention Study Using a Sentinel Surveillance Network of Physicians
- ClinicalTrials.gov ID
- NCT01358916
- Acronym / sponsor ID
- SAPI / Swiss Federal Office of Health
- Keywords
- antimicrobial resistance, antibiotic prescription, primary health care, cluster-randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Bundesamt für Gesundheit, Sentinella Netzwerk, Schweizerische Gesellschaft für Infektiologie, Pädiatrische Infektiologie Gruppe Schweiz
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 May 2011 (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.
Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a major driving force for the development of resistance. Thus optimization of antibiotic prescription and reduction of unnecessary antimicrobial treatment are essential in the prevention and reduction of antimicrobial resistance rates.
The goal of this study is the improvement of antibiotic prescription in outpatient care. The study will take place within a Swiss-wide sentinel surveillance network of physicians. The participating physicians will be randomised in a control and intervention group. The intervention group will receive therapeutic guidelines for the treatment of upper and lower respiratory tract infections and lower urinary tract infection as well as regular feed-backs on the prescription pattern of the sentinel physicians during the past months. Sentinel physicians will collect information about each antibiotic prescription, its indication and characteristics of the patient.
Our hypothesis is that the prescription pattern in the intervention group will be optimised and unnecessary antibiotic therapy will be reduced compared to the control group.
Detailed description
Background
Antimicrobial resistance has become a world-wide problem and antibiotic consumption is a major driving force for the development of resistance. Thus optimization of antibiotic prescription and reduction of unnecessary antimicrobial treatment are essential in the prevention and reduction of antimicrobial resistance rates.
The goal of this study is the qualitative and quantitative improvement of antibiotic prescription in outpatient care. The study will take place within a Swiss-wide sentinel surveillance network consisting of general practitioners, pediatricians and physicians specialized in internal medicine. The participating physicians will be randomised in a control and intervention group. The intervention group will receive therapeutic guidelines for the treatment of upper and lower respiratory tract infections and lower urinary tract infections. Furthermore, regular feed-backs on the prescription pattern of the sentinel physicians in the last months will be provided.
Information about each antibiotic prescription, its indication and the characteristics of the patients will be collected by the sentinel physicians. The standardized reporting of antibiotic prescription by sentinel physicians has been carried out in Switzerland since 2006.
Our hypothesis is that the intervention will affect the antibiotic prescription pattern and that the investigators will observe an optimization of antibiotic prescription and a decrease in the number of antibiotic prescriptions.
Objective
Primary goals:
- Increase of the percentage of penicillin prescriptions for upper and lower respiratory tract infections
- Increase of the percentage of TMP/SMX prescriptions for lower urinary tract infections in adults
Secondary goal:
- Decrease of the percentage of quinolone prescriptions for COPD exacerbations in adults
- Decrease of the number of antibiotic prescriptions for sinusitis and other upper respiratory tract infections
Methods
Prospective cluster-randomised intervention study. The intervention is the mailing of treatment guidelines for upper and lower respiratory tract infections and lower urinary tract infections as well as regular feed-backs on the antibiotic prescription patterns of the sentinel physicians during the past months.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual information policy | No intervention | –No specific intervention |
| Antibiotic therapy guidelines | Other | Other: Mailing of antibiotic therapy guidelines to the sentinel physicians |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with respiratory tract infections or urinary tract infections
Key exclusion criteria (1 listed)
- Patients with chronic disease requiring regular antibiotic treatment
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 |
|---|---|---|
| Mailing of antibiotic therapy guidelines to the sentinel physiciansMailing of antibiotic therapy guidelines to the sentinel physicians and regular feedback on antibiotic prescription | Other | Antibiotic therapy guidelines |
Primary outcome
Percentage of prescriptions of penicillin for respiratory tract infections
Time frame: Two years
Percentage of prescriptions of TMP/SMX for lower urinary tract infections in adults
Time frame: Two years
2 secondary outcomes
Percentage of prescriptions of quinolone for COPD exacerbations in adults
Time frame: Two years
Percentage of antibiotic prescriptions for the indications "sinusitis" and "other upper respiratory tract infections"
Time frame: Two years
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 29 Mar 2013.
- Derived from this study: PubMed 25326088Hurlimann D, Limacher A, Schabel M, Zanetti G, Berger C, Muhlemann K, Kronenberg A; Swiss Sentinel Working Group. Improvement of antibiotic prescription in outpatient care: a cluster-randomized intervention study using a sentinel surveillance network of physicians. J Antimicrob Chemother. 2015 Feb;70(2):602-8. doi: 10.1093/jac/dku394. Epub 2014 Oct 17.
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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.
Andreas Kronenberg, Dr. med. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mailing of antibiotic therapy guidelines to the sentinel physicians in people with Respiratory Tract Infections and Urinary Tract Infections, run by University of Bern at 1 site in Switzerland.
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 1 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
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?
Percentage of prescriptions of penicillin for respiratory tract infections (time frame: Two years). The study lists 2 primary outcomes in all. 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 NCT01358916, which also lists 1 linked publication.
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 29 Mar 2013.