Urinary tract infections Urological and Genital Diseases
Conditions
Interventions
The IPAP-UTI RCTs will be conducted in areas of England with the worst AMR problems, and will include the patient groups most affected, reporting differences across age, socioeconomic and ethnic group
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RCT 1: Target (trimethoprim) AMR measured in E. coli urinary isolates between episodes of UTI in women aged 16+ years RCT 2 & RCT 3: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| RCT 1: 1. Treatment failure within episodes of UTI in women aged 16+ years; this is defined as the samples =14-days from the 1st sample of each episode 2. Alternative Antibiotic (pivmecillinam and fosfomycin for penicillin allergic patients) AMR in E. coli urinary isolates between episodes of UTI* in women aged 16+ years. 3. Non-Target and Non-Alternative Antibiotic AMR rates in E. coli urinary isolates between episodes of UTI* in women aged 16+ years 4. AMR risk in all E. coli urinary isolates from women aged 16+ years 5. Rates of positive UTI urine samples per 1,000 registered patients in women aged 16+ years 6. Dispensing rates of specific and total antibiotics per 1,000 registered patients in all adults aged 16+ years 7. Rates per 1,000 registered patients for: (i) Emergency Department (ED) attendances for UTI; (ii) Emergency Department (ED) attendances for sepsis (iii) hospital admissions for UTI; (iv) hospital admissions for BSI; and (v) all cause death in those attending the ED for UTI or sepsis, or admitted for UTI or BSI. S7 i-v will be linked to AMR status where available in women aged 16+ years 8. This will repeat the primary and all of the secondary outcomes (P1, S2-S4) that were specific to E. coli urinary isolates using all urinary isolates from all adults aged 16+ years 9. The primary and selected secondary outcomes (P1, S2-S5, S8) tabulated alongside the costs of the intervention and healthcare utilisation at the GP practice level, including hospital admissions for UTI-related conditions, ED attendances due to the symptoms of UTI and antibiotic prescriptions for UTI, and where accessible primary care consultations for UTI 10. Rates per 1,000 registered patients for: (i) repeat UTI primary care consultations; and (ii) repeat antibiotic dispensing =2 weeks, and =4 weeks of UTI, in women aged 16+ years RCT 2 & RCT 3: The details of each RCT including outcomes will be developed once the ICBs have been identified and interventions agreed, and they will b | — |
Countries
England, United Kingdom
Outcome results
None listed