6.1
The contract between the company and NHS England requires the company to participate in the UK Antimicrobial Registry (UKAR), developed by the British Society for Antimicrobial Chemotherapy (BSAC) in partnership with the University of Aberdeen. This registry will provide information on the relationship between patterns of antimicrobial usage and emergence of resistance in the UK, and will provide quantitative data on clinical and safety outcomes. The UKAR registry and other surveillance and monitoring programmes in England for antimicrobials, for example Blueteq, should capture the following information:
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Anatomical site of clinical infection.
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Type of sample, for example, sputum, tracheal, bronchial wash, pleural aspirate.
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Pathogen and mechanism of antimicrobial resistance:
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When the results of microbiological or gene tests are available: record the confirmed pathogen, confirmed resistance mechanism and the antimicrobial agents the pathogen is susceptible to.
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If the antimicrobial is used empirically when results of microbiological or gene tests are not yet available, record the suspected pathogen and resistance mechanism.
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Data should capture whether the confirmed pathogen and resistance mechanism differed from that suspected in the empirical setting.
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Clinical outcomes including, but not limited to, mortality (including all-cause mortality and mortality attributable to the infection), clinical cure (resolution of signs or symptoms of infection and no further antimicrobial therapy needed) and microbiological eradication.
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Safety outcomes including acute kidney injury, renal replacement therapy, colonisation with a multi-drug-resistant pathogen after treatment and Clostridium difficile
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Resource use outcomes including length of hospital stay by ward type and duration of treatment with antimicrobials.