Is 7 days of antibiotics as effective as 14 days of antibiotics for the 'cure' of urinary sepsis: an observational sub-study of the BALANCE Study.

Not Applicable

• Conditions: rinary tract infection; Urinary sepsis; Bacteraemia; Urinary tract infection; Infection - Studies of infection and infectious agents; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12620001108909
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-26
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 284

Inclusion Criteria

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
AND
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.
AND
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.
OR
ii.A urine culture has isolated mixed bacteria for which individual species have not been characterised
OR
iii.A urine culture collected after antimicrobial therapy demonstrates a WCC count consistent with a urinary source of sepsis, based on local interpretation guidelines

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified