The Bacteriuria in Renal Transplantation (BiRT) study: a prospective, randomized, parallel-group, multicenter, open-label, superiority trial comparing antibiotics versus no treatment in the prevention of symptomatic urinary tract infection in kidney transplant recipients with asymptomatic bacteriuria

NA (ongoing trial)

Journal Ref. The BiRT study protocol has been published by The Lancet (
Intervention Drug - Antibiotics (10 days): started according to the antibiogram results. The choice of antimicrobial agents is at the discretion of the physician.
Number of sites 15
Countries involved Belgium, France
Sample size 198
Type of statistical analyses Outcome parameters will be primarily analyzed according to the intention-to-treat principle. The intention-to-treat analysis will include all patients randomly assigned to the antibiotics group (n=99) or control group (n=99). The effect of the two strategies on the risk of a first symptomatic urinary tract infection will be compared using the Pearson's chi-square test or Fischer's exact test, as appropriate, and expressed as the odds ratio (OR) with 95% confidence interval (95% CI). We will use Kaplan-Meier survival curves to estimate the cumulative incidence of symptomatic urinary tract infection. The curves will be compared using log-rank test. A bilateral p-value of < 0.05 will be used to reject the null hypothesis in all hypothesis testing.
Participant characteristics Age: ≥ 18 years
Condition: Asymptomatic bacteriuria in kidney transplant recipients
Baseline severity:
Duration of trial 12 months
Primary outcome Cumulative incidence of a first episode of symptomatic urinary tract infection (Time frame: 12 months)
Show Score Ranges


(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
4.5 5 4 5 5 5 4.5 4 5