Urinary Tract InfectionsATB-IUNCT03928951
General Practitioner Reassessment of Urinary Infection Antibiotherapy Prescribed by Emergency Departments
An observational study of Urinary Tract Infections, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2019to 12 Sep 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting in emergency departments of Toulon La Seyne sur Mer hospital because of a urinary infection and to whom antibiotherapy is prescribed
Who may be able to join
- Every patient more than 18 years who was administered antibiotherapy for urinary infection in emergency department or for whom urinary infection was diagnosed in emergency department (cystitis, acute pyelonephritis, prostatitis)
Who cannot join
- Patients less than 18 years old
- Patients opposed to their data use
- Patients hospitalized more than 24 hours
- Patients taking antibiotherapy already before their arrival in emergency department
- Patients without sufficient reading capacities or understanding of french language to express opposition to their research participation
- Any other reason which, according to investigator, might interfere with research objective evaluation
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, Var, 83056
About this study
Official title: General Practitioner Reassessment of the Antibiotherapy of Urinary Infections Initially Treated in Emergency Departments
Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments. This will allow assessing the quality of initial antibiotic prescription and help to improve practices.
Read the detailed description
Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments.
Patients will be informed during their consultation in one of Toulon - La Seyne sur Mer hospital emergency departments. If they don't express opposition to their data collection, they will be included. A form will then be completed by emergency physicians with initial prescribed antibiotherapy, patients' general practitioners contact information and if patients have a shared medical file or not. 4 to 5 days later, patients' general practitioners will be contacted to know if urinary analysis results were transferred from emergency department to practitioners, if antibiotherapy was modified and if patients' shared medical file was consulted.
- Conditions
- Urinary Tract Infections
- Being tested
- General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments
- Keywords
- Urinary infections, Antibiotherapy, Emergency, Reassessment
- Medical subject headings
- Urinary Tract Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departmentsOther
Antibiotherapy will be prescribed by emergency physicians and general practitioners will be contacted 4 to 5 days later to know if antibiotherapy was modified
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from urinary infection | Patients consulting in one of Toulon - La Seyne sur Mer hospital emergency departments because of urinary infection Receives: Other: General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of antibiotherapies modified by general practitioners
Number of antibiotic prescriptions modified by general practitioners divided by the total number of initial antibiotic prescriptions
Measured: 6 months
Secondary outcomes (5)
Rate of initial antibiotherapies not relevant to recommendations
Number of initial antibiotic prescriptions not relevant to recommendations divided by the total number of initial antibiotic prescriptions
Measured: 6 months
Rate of initial antibiotherapies not consistent with recommendations
Number of initial antibiotic prescriptions not consistent (molecule, dose, period of time) with recommendations divided by the total number of initial antibiotic prescriptions
Measured: 6 months
Rate of reassessments not relevant to recommendations
Number of antibiotic prescription modifications not relevant to recommendations divided by the total number of antibiotic prescription modifications
Measured: 6 months
Rate of reassessments not consistent with recommendations
Number of antibiotic prescription modifications not consistent (molecule, dose, period of time) with recommendations divided by the total number of antibiotic prescription modifications
Measured: 6 months
Frequence of use of shared medical file
Number of patients for which the shared medical file is used divided by the total number of patients enrolled
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start14 Jun 2019
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouna EL OMRI, MD, Study director, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928951
- Sponsor's protocol ID
- 2019-CHITS-01
- Acronym
- ATB-IU
- Status last verified
- Nov 2019
- First submitted
- 24 Apr 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Practitioner Reassessment of the Antibiotherapy of Urinary Infections Initially Treated in Emergency Departments
- ClinicalTrials.gov ID
- NCT03928951
- Acronym / sponsor ID
- ATB-IU / 2019-CHITS-01
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary infections, Antibiotherapy, Emergency, Reassessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 26 Apr 2019 (actual)
- 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.
Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments. This will allow assessing the quality of initial antibiotic prescription and help to improve practices.
Detailed description
Urinary infections are at the origin of many emergency department consultations and antibiotic prescriptions. Increase of bacteria resistance to antibiotics is promoted by an inappropriate use of those antibiotics but initial prescription in emergency departments is complicated by brief clinical examinations, unavailable sampling results and risks of multi-resistant bacteria. Large diffusion of new recommendations for urinary infection management should improve the quality of initial antibiotic prescription. However emergency physicians have no knowledge of the reassessment of antibiotherapy 48 to 72 hours after initial prescription by general practitioners which is a quality criterion of good antibiotic use. The main purpose of this study is to estimate the reassessment rate by general practitioners of the urinary infection antibiotherapies prescribed in emergency departments.
Patients will be informed during their consultation in one of Toulon - La Seyne sur Mer hospital emergency departments. If they don't express opposition to their data collection, they will be included. A form will then be completed by emergency physicians with initial prescribed antibiotherapy, patients' general practitioners contact information and if patients have a shared medical file or not. 4 to 5 days later, patients' general practitioners will be contacted to know if urinary analysis results were transferred from emergency department to practitioners, if antibiotherapy was modified and if patients' shared medical file was consulted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from urinary infection | – | Other: General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departmentsPatients consulting in one of Toulon - La Seyne sur Mer hospital emergency departments because of urinary infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting in emergency departments of Toulon La Seyne sur Mer hospital because of a urinary infection and to whom antibiotherapy is prescribed
Key inclusion criteria (1 listed)
- Every patient more than 18 years who was administered antibiotherapy for urinary infection in emergency department or for whom urinary infection was diagnosed in emergency department (cystitis, acute pyelonephritis, prostatitis)
Key exclusion criteria (6 listed)
- Patients less than 18 years old
- Patients opposed to their data use
- Patients hospitalized more than 24 hours
- Patients taking antibiotherapy already before their arrival in emergency department
- Patients without sufficient reading capacities or understanding of french language to express opposition to their research participation
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 |
|---|---|---|
| General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departmentsAntibiotherapy will be prescribed by emergency physicians and general practitioners will be contacted 4 to 5 days later to know if antibiotherapy was modified | Other | Patients suffering from urinary infection |
Primary outcome
Rate of antibiotherapies modified by general practitioners
Time frame: 6 months
Number of antibiotic prescriptions modified by general practitioners divided by the total number of initial antibiotic prescriptions
5 secondary outcomes
Rate of initial antibiotherapies not relevant to recommendations
Time frame: 6 months
Rate of initial antibiotherapies not consistent with recommendations
Time frame: 6 months
Rate of reassessments not relevant to recommendations
Time frame: 6 months
Rate of reassessments not consistent with recommendations
Time frame: 6 months
Frequence of use of shared medical file
Time frame: 6 months
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 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Mouna EL OMRI, MD study director
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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 6 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 Nov 2019. 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 France. 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?
Rate of antibiotherapies modified by general practitioners (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2019.