Selective Reporting of Antibiotic Susceptibility Test Results in Urinary Tract Infections in the Outpatient Setting
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|ClinicalTrials.gov Identifier: NCT03612297|
Recruitment Status : Unknown
Verified June 2018 by Central Hospital, Nancy, France.
Recruitment status was: Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Antibiotic resistance is a serious and increasing worldwide threat to global public health. One of antibiotic stewardship programmes' objectives is to reduce inappropriate broad-spectrum antibiotics' prescription. Selective reporting of antibiotic susceptibility test (AST) results, which consists of reporting to prescribers only few (n=5-6) antibiotics, preferring first-line and narrow-spectrum agents, is one possible strategy advised in recommendations. However, selective reporting of AST has never been evaluated using an experimental design.
This study is a pragmatic, prospective, multicentre, controlled (selective reporting vs usual complete reporting of AST), before-after (year 2019 vs 2017) study. Selective reporting of AST is scheduled to be implemented from September 2018 in the ATOUTBIO group of 21 laboratories for all E. coli identified in urine cultures in adult outpatients, and to be compared to the usual complete AST performed in the EVOLAB group of 20 laboratories. The main objective is to assess the impact of selective reporting of AST for E. coli positive urine cultures in the outpatient setting on the prescription of broad-spectrum antibiotics frequently used for urinary tract infections (amoxicillin-clavulanate, third generation cephalosporins and fluoroquinolones). The primary endpoint is the after (2019) - before (2017) difference in prescription rates for the previously mentioned antibiotics/classes that will be compared between the two laboratory groups, using linear regression models. Secondary objectives are to evaluate the feasibility of selective reporting of AST implementation by French laboratories and their acceptability by organising focus groups and individual semi-structured interviews with general practitioners and laboratory professionals.
|Condition or disease||Intervention/treatment|
|Urinary Tract Infections||Diagnostic Test: Selective reporting of Antibiotic Susceptibility Tests|
|Study Type :||Observational|
|Estimated Enrollment :||64000 participants|
|Official Title:||Impact of Selective Reporting of Antibiotic Susceptibility Test Results in Urinary Tract Infections in the Outpatient Setting: a Protocol for a Pragmatic, Prospective Quasi-experimental Trial|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||April 30, 2020|
Selective reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults.
Diagnostic Test: Selective reporting of Antibiotic Susceptibility Tests
Selective reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults: results of susceptibility are reported back to the practitioner only for few (n=5-6) antibiotics, those that should be used in first line according to guidelines. Susceptibility results not mentioned in the selective reporting of AST are available at the practitioners' request to the microbiologist. Data used to determine which antibiotic to report for UTIs are the isolated microorganism, the patient age and gender, and antibiotics recommended in national guidelines. As guidelines for UTIs treatment differ by gender, two algorithms have been developed and pilot-tested by three GPs, one microbiologist and two infectious disease physicians.
Complete reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults.
- Impact of selective reporting of AST for E. coli positive urine cultures in outpatient setting on the prescription of broad-spectrum antibiotics frequently used on UTIs (amoxicillin-clavulanate, third generation cephalosporins and fluoroquinolones) [ Time Frame: 2 years (1 year before + 1 year after) ]A comparison of the after (2019) - before (2017) difference of the prescription rates for previous mentioned antibiotics/classes between the two groups, using linear regression models adjusted for variables that differ between groups (laboratory activities, sex-ratio, age).
- Laboratory expenditures (in euros) for the implementation of the intervention [ Time Frame: 2 years ]Collection of all laboratory expenditures made in euros in 2018 and 2019 for the implementation of the selective reporting of AST.
- Satisfaction of GPs and laboratory staffs about selective reporting of AST, assessed by a visual analog scale [ Time Frame: 1 year ]The visual analog scale is a likert scale varying from 0 to 10. Satisfaction will be collected by organizing focus groups and individual semi-structured interviews with a randomised sample of GPs and laboratory staffs one year after the selective reporting of AST implementation (September 2019).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612297
|Contact: Céline Pulcini, Professor||+33 email@example.com|
|Principal Investigator:||Céline Pulcini, Professor||Central Hospital, Nancy, France|