None listed
Conditions
Brief summary
The BALANCE study is a randomised clinical trial comparing 7 to 14 days of antimicrobial therapy for bacteraemia. This sub-study is designed to determine whether patients enrolled in the main study, with a urinary source of their bacteraemia (urinary sepsis/urinary-tract infection), are as likely to be cured from their urinary-tract infection when treated with a short duration (7d) antimicrobial therapy, as compared with a longer duration (14d) of therapy. Demonstrating a clinical cure of the primary source of infection is important in UTI. If microbiological cure of the infection is not achieved, patients remain at increased risk of recurrent urinary tract infection and sepsis. If the BALANCE study demonstrates non-inferiority of 7 days duration antimicrobial therapy, further data supporting non-inferiority of cure for UTI will enhance the generalisability and clinician acceptance of reduced duration antimicrobial therapy.
Interventions
This is an observational sub-study of the main BALANCE Study (NCT03005145). The intervention in the main BALANCE study is a shorter duration antimicrobial therapy (7d) compared with a longer duration (14d).
This sub-study is gathering enhanced data and additional end-points on participants with a urinary tract source of sepsis, who are enrolled BALANCE. The primary outcome of this sub-study is measured with the collection of a mid-stream urine sample 6-12 days after completion of study-defined a
This is an observational sub-study of the main BALANCE Study (NCT03005145). The intervention in the main BALANCE study is a shorter duration antimicrobial therapy (7d) compared with a longer duration (14d). This sub-study is gathering enhanced data and additional end-points on participants with a urinary tract source of sepsis, who are enrolled BALANCE. The primary outcome of this sub-study is measured with the collection of a mid-stream urine sample 6-12 days after completion of study-defined antimicrobial therapy. Additional data on symptoms and clinical outcomes are measured by survey questions at the same time-point and at 90 days after the onset of bacteraemia.
Sponsors
Monash University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed