| Journal Ref. |
The BiRT study protocol has been published by The Lancet (http://www.thelancet.com/protocol-reviews/14PRT-5447). |
| 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) |
