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General Practitioner Reassessment of Urinary Infection Antibiotherapy Prescribed by Emergency Departments (ATB-IU)

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ClinicalTrials.gov Identifier: NCT03928951
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Tracking Information
First Submitted Date April 24, 2019
First Posted Date April 26, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date June 14, 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 24, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03928951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 24, 2019)
  • Rate of initial antibiotherapies not relevant to recommendations [ Time Frame: 6 months ]
    Number of initial antibiotic prescriptions not relevant to recommendations divided by the total number of initial antibiotic prescriptions
  • Rate of initial antibiotherapies not consistent with recommendations [ Time Frame: 6 months ]
    Number of initial antibiotic prescriptions not consistent (molecule, dose, period of time) with recommendations divided by the total number of initial antibiotic prescriptions
  • Rate of reassessments not relevant to recommendations [ Time Frame: 6 months ]
    Number of antibiotic prescription modifications not relevant to recommendations divided by the total number of antibiotic prescription modifications
  • Rate of reassessments not consistent with recommendations [ Time Frame: 6 months ]
    Number of antibiotic prescription modifications not consistent (molecule, dose, period of time) with recommendations divided by the total number of antibiotic prescription modifications
  • Frequence of use of shared medical file [ Time Frame: 6 months ]
    Number of patients for which the shared medical file is used divided by the total number of patients enrolled
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title General Practitioner Reassessment of Urinary Infection Antibiotherapy Prescribed by Emergency Departments
Official Title General Practitioner Reassessment of the Antibiotherapy of Urinary Infections Initially Treated in Emergency Departments
Brief 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, 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
Condition Urinary Tract Infections
Intervention Other: General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments
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 Groups/Cohorts Patients suffering from urinary infection
Patients consulting in one of Toulon - La Seyne sur Mer hospital emergency departments because of urinary infection
Intervention: Other: General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 24, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anaïs MAUGARD 04 94 14 55 29 ext +33 Anais.maugardlandre@ch-toulon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03928951
Other Study ID Numbers 2019-CHITS-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study Sponsor Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators Not Provided
Investigators
Study Director: Mouna EL OMRI, MD Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
PRS Account Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Verification Date July 2019