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Lowering catheter-associated urinary tract infections (CATION study): Statistical Analysis Plan

Mitchell, B.; White, N. M.; Cheng, A.; Russo, P.; Brain, D.; Tehan, P.; Matterson, G.; King, J.; Havers, S.; Browne, K.

2026-06-29 infectious diseases
10.64898/2026.06.24.26356490 medRxiv
Show abstract

The CATION study is a parallel two-arm randomised controlled trial on the prevention of catheter-associated urinary tract infections (CAUTI) in hospitalised patients. The intervention is the use of a sterile wipe containing 0.1% chlorhexidine solution for meatal cleaning prior to urinary catheter insertion as part of usual care; the intervention will be compared with the use of a sterile wipe containing 0.9% normal saline as the control. This document is the Statistical Analysis Plan for evaluating primary, secondary and tertiary effectiveness outcomes. The trial was preregistered on the Australian and New Zealand Clinical Trials registry (ACTRN12625000278437). A copy of the study protocol and a signed version of this Statistical Analysis Plan are available on request from the corresponding author (BM).

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