Impact of a shorter (7 days) compared with a longer (14d) duration of antimicrobial therapy on the treatment of bacteraemic urinary sepsis, measured by microbiological success after the completion of therapy: A sub-study of the BALANCE study.

Monash University0 个研究点目标入组 284 人开始时间: 2020年10月26日最近更新: 2020年11月2日

适应症

试验速览

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•1)The participant has been enrolled and randomised in the BALANCE study
•2)The source of bacteraemia is most likely to originate from the urinary tract as evidenced by:
•a.The enrolling clinician believes that the urinary tract is the ‘most likely’ source of the bacteraemia
•b.Routine clinical work-up has not identified another ‘probable’ source of the bacteraemia
•3)The participant has a urine microscopy and culture result on a fresh urine sample (not from the drainage bag of a urinary catheter) supporting the urinary tract as a source of bacteraemia as evidenced by the presence of A & B:
•a.The urine culture has been collected during the same episode of acute illness associated with the bacteraemia.
•b.Microbiological findings are supportive of a urinary source. An acceptable supportive result is ANY of the three criteria below:
•i.A urine culture has isolated the same bacteria (genus & species) as the blood culture. The antimicrobial resistance phenotype (antibiotic susceptibility pattern) may vary from the blood isolate.
•ii.A urine culture has isolated mixed bacteria for which individual species have not been characterised
•iii.A urine culture collected after antimicrobial therapy demonstrates a WCC count consistent with a urinary source of sepsis, based on local interpretation guidelines

•1)Male participants with suspected or confirmed prostatitis
•2)Participants with an Ileal loop or vesicoureteric reflux
•3)Participants who are unable or unwilling to provide a follow-up urine sample for culture within the specified study time-frame.

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