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About This Study

POETIC is part of a larger study called R-GNOSIS which is funded by the EU Seventh Framework Programme (FP7). POETIC is led by Professor Chris Butler, Cardiff University. In summary, R-GNOSIS (Resistance in Gram-Negative Organisms: Studying Intervention Strategies) combines 5 international clinical intervention studies, all supported by highly innovative microbiology and mathematical modelling, to determine - in the most relevant patient populations - the efficacy and effectiveness of cutting-edge interventions to reduce acquisition, carriage, infection and spread of Multi-Drug Resistant Gram-negative Bacteria (MDR-GNB). The studies and analyses proposed in R-GNOSIS will generate a step-change in identifying evidence-based preventive measures and clinical guidance for primary care and hospital-based physicians, as well as health-care authorities, to combat the spread and impact of the unprecedented rise of infections caused by MDR-GNB in Europe.

POETIC Study Summary

POETIC is an evaluation of a novel Point of Care Test (POCT) guided urinary tract infection (UTI) management strategy for use in adult women presenting in primary care with suspected uncomplicated UTI. The POCT will provide clinicians, at the point of care, within 24 hours, with a diagnosis of bacterial UTI and resistance profiles of any identified pathogen to the antibiotics most commonly used for UTI in primary care. The study will determine whether or not this information aids clinicians to more appropriately prescribe antibiotics for uncomplicated UTI’s (i.e. avoid the use of antibiotics for women where no bacterial infection is identified, and where a bacterial infection is identified, to ensure the narrowest spectrum antibiotic is prescribed appropriate to the sensitivity of the infecting organisms). Urine samples will also be sent for culture in local microbiology laboratories, and the appropriateness of the decision whether or what antibiotic to prescribe, will be assessed in comparison to the results obtained from laboratory (as opposed to POCT) culture. The study is being carried out in 4 European networks: Wales, England, Netherlands and Spain, and is divided into four stages as outlined below.

POETIC Stage 3: Randomised Controlled Trial (RCT)

The RCT aims to quantify the costs and effects of an optimised POCT guided diagnostic and treatment regime for symptoms of uncomplicated UTI. 540 adult female patients from the 4 participating countries will be randomised to either the POCT arm or the standard care (SC) arm. Participants randomised to the intervention arm will have their treatment guided by the Flexicult™ POCT. This strategy will be based upon guidelines on the management of uncomplicated UTI in primary care in participating countries, and use of a POCT to guide antibiotic management. Urine and stool samples will be obtained at presentation (baseline) and two weeks later. The primary outcome will be appropriateness of antibiotic prescribing (see below for participant flow diagram). 

POETIC Stage 4: Implementation Phase

A non-randomised pragmatic implementation study will be performed to evaluate the impact of the optimised POCT diagnostic strategy in community practice. Clinicians from approximately 10 general practices (approximately half of whom participated in the stage 3 RCT) will have the POCT optimised management strategy available for use at their discretion and will audit their use of the POCT by recording anonymised data on patients with suspected UTI, whether or not they used the POCT, and the reasons. A selection of these clinicians and patients will be interviewed to explore expectations and experiences regarding POCT use and barriers and opportunities to uptake of the POCT into routine care. A non-randomised pragmatic implementation study will be performed to evaluate the impact of the optimised POCT diagnostic strategy in community practice. Clinicians from approximately 10 general practices (approximately half of whom participated in the stage 3 RCT) will have the POCT optimised management strategy available for use at their discretion and will audit their use of the POCT by recording anonymised data on patients with suspected UTI, whether or not they used the POCT, and the reasons. A selection of these clinicians and patients will be interviewed to explore expectations and experiences regarding POCT use and barriers and opportunities to uptake of the POCT into routine care.