Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum … (NCT06067386) | Clinical Trial Compass
UnknownNot Applicable
Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs
France3,000 participantsStarted 2023-11-21
Plain-language summary
The control of antibiotic resistance requires a reduction in inappropriate prescriptions of broad-spectrum antibiotics (amoxillin-clavulanate (AMC), fluoroquinolones (FQ), third-generation cephalosporins (C3G)), particularly for urinary tract infections treated in primary care. Several studies have reported the positive impact of antibiotic susceptibility testing performed on urine cultures on the appropriate use of antibiotics.
The "selective reporting for antibiotic susceptibility testing ", defined as the restriction of the list of antibiotics mentioned in the report according to the antibiotic resistance profile, would allow, according to observational studies, a reduction of 25 to 70% of the initial prescriptions of broad-spectrum antibiotics and a 20% rate of antibiotic de-escalation (=reduction of the antibacterial spectrum of an antibiotic treatment after re-evaluation).
The objective is to assess the impact of disseminating a selective reporting for antibiotic susceptibility testing on the dispensing of broad-spectrum antibiotics prescribed by general practitioners (GPs) for E. coli positive urine cultures in adult women, compared to the dissemination of a standard antibiotic susceptibility testing.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients :
* women ≥18 years of age,
* affiliated with the CPAM of Loire Atlantique (44) or Maine et Loire (49),
* with a urine culture: i) analyzed by LabOuest, ii) positive for E. coli, and iii) associated with a prescription for antibiotics by a general practitioner in the period 7 days before and 14 days after the antibiotic susceptibility testing.
General practitioners :
* practicing in primary care Loire Atlantique (44) and/or Maine et Loire (49),
* having been consulted by at least 100 different patients in the 12 months prior to baseline,
* having received at least one urine culture result for a woman ≥18 years of age analyzed by LabOuest over the 12 months prior to baseline.
Exclusion Criteria:
Patients :
* hospitalized in the period 7 days before and 14 days after antibiotic susceptibility testing (data on antibiotics dispensed in healthcare institutions are not accessible via DCIR data),
* with reimbursements for antibiotics prescribed by physicians in different practices over the period 7 days before and 14 days after antibiotic susceptibility testing.
General practitioners :
* with a special practice (acupuncture, allergology, angiology).
* not receiving any urine culture results analyzed by a laboratory of the LabOuest network in the year following the intervention
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.