Improving primary care antibiotic prescribing to reduce antibiotic resistant urine infections: the IPAP-UTI series of cluster randomised controlled trials

Not Applicable

• Conditions: rinary tract infections; Urological and Genital Diseases

• Registration Number: ISRCTN12732520
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Last Update Posted: 26 August 2024
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

This is a cluster RCT and individual patients are not recruited. Data for the study will only include male and female patients, aged 16 years and over.

Inclusion criteria for ICBs:
ICBs in England are eligible for the study if they are actively contributing to the UKHSA voluntary national surveillance of UTI AMR. See master protocol, supplementary material A for further details of ICB selection criteria, which was developed to assess ICB eligibility based on UKHSA routinely collected national UTI AMR data, and UKHSA national antibiotic dispensing data (both datasets at ICB and GP practice level).

Inclusion criteria for GP practices:
GP practices will be eligible if providing within office hours standard NHS care. We will consider additional eligibility criteria where necessary, including restricting to NHS GP practices where:
1. >=40% of registered patients are female
2. There are at least 100 registered patients
GP practices supporting individually randomised patient RCTs of different antibiotics for UTIs may take part in the IPAP-UTI RCTs.

Qualitative interviews:
A purposive sample, of up to 20 prescribing clinicians and ICB staff involved in implementation of the intervention will be recruited to take part in interviews for the qualitative process evaluation. We will aim for a maximum diversity sample in terms of practice population diversity, to ensure data is captured from a range of settings.

Exclusion Criteria

1. ICBs taking, or planning to take, part in other cluster RCTs involving an intervention to change antibiotic prescribing for UTIs will be excluded.
2. GP practices taking part in other cluster RCTs involving an intervention to change antibiotic prescribing for UTIs will be excluded.
3. The routinely collected data used in the RCTs will be restricted to male and female patients aged 16 years and over.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RCT 1:<br>Target (trimethoprim) AMR measured in E. coli urinary isolates between episodes of UTI in women aged 16+ years<br><br>RCT 2 & RCT 3:<br>The details of each RCT including outcomes will be developed once the ICBs have been identified and interventions agreed, and they will be fully described in Appendices and submitted for approval when ready.