CompletedNot Applicable

Infectious Diseases Experts as Part of the Antibiotic Stewardship Team in Primary Care

Spain1,389 participantsStarted 2021-06-01

Plain-language summary

A cluster-randomised multicentre blinded clinical trial will be performed in six primary care centres located in the southern metropolitan area of Barcelona (Spain). The objective is to assess whether including experts on infectious diseases (ID) within the antimicrobial stewardship (AMS) team of primary care achieves higher reductions on overall antibiotic consumption and increases the quality of prescription in diagnosed upper respiratory and urinary tract infections. Centres will be randomly assigned to receive a standard-AMS or an advanced-AMS (intervention). Advanced-AMS includes all standard-AMS strategies plus general practitioner chance to discuss clinical cases by telephone to ID expert on working days (8:00 am to 8:00 pm), and by biweekly meetings.

Who can participate

Age range

15 Years

Sex

ALL

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 at centre-level (clusters) * Primary care centres belonging to the Delta del Llobregat healthcare area. * Prior experience in clinical research and formal agreement to participate in the study. * Comparability of their reference populations. All general practitioners of the 6 primary care centers will be included in our clinical trial, excepting paediatricians. Data collection will be performed on patients attended in these centres. Inclusion and exclusion criteria will be applied on the patients attended by general practitioners: Inclusion criteria at patient-level criteria (unit for secondary objectives) * Adult patients (aged \>14 years). * Diagnosed with an acute URTI (including pharyngoamygdalitis, sinusitis, otitis) or UTI (including cystitis, prostatitis, pyelonephritis) during the study period. * Patients attended by a GP at the selected centres. Eligible patients will be identified following the International Classification of Diseases (ICD-10) CM codes as follows: * URTI: J00, J01, J02, J03, J04, J05, J06, J31, J39, H60, H62, H65, H66, H67, H83 and H92. * UTI: N10, N30, N39, N41, R82 and O23. Exclusion criteria: * Patients less than 14 years old. * Patients with indwelling urinary catheter. * Patients with congenital urinary tract abnormalities. * Pregnant women. * Patients undergoing urological surgery.

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.

What they're measuring

To asses the impact of implementing an advanced-AMS program (inclusion of infectious diseases specialists) on the overall antibiotic consumption.

Timeframe: Through study completion

Trial details

NCT IDNCT04848883

SponsorInstitut d'Investigació Biomèdica de Bellvitge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-21

View on ClinicalTrials.gov More Infectious Disease trials