Transplant Trial Watch

Antibiotic Treatment Versus No Treatment for Asymptomatic Bacteriuria in Kidney Transplant Recipients: A Multicenter Randomized Trial.

Sabe, N., Oriol, I. et al. (2019).

Open Forum Infectious Diseases 6(6):ofz243.


Aims
This study aimed to test the evaluate the impact of no treatment for Asymptomatic Bacteriuria (AB) in kidney transplant recipients vs antibiotic treatment in the prevention of acute graft pyelonephritis (AGP).

Interventions
Patients with AB were assigned no treatment or antibiotic treatment.

Participants
205 kidney transplant recipients were enrolled in the study and underwent randomization. Of these participants, 102 were assigned to the antibiotic treatment group and 103 were assigned to the no treatment group.

Outcomes
The primary outcome was the occurrence of AGP. Secondary endpoints included: bacteremic AGP, cystitis, susceptibility of urine isolates, graft rejection, graft function, graft loss, opportunistic infections, need for hospitalization, and mortality.

Follow-up
12 months

CET Conclusions
This multicentre trial investigated whether antibiotic treatment of asymptomatic bacteriuria improved outcomes in renal transplant recipients. The authors found no difference in risk of graft pyelonephritis or transplant outcomes, with a suggestion of increased bacterial resistance in the treated arm. These findings should be interpreted with caution, as the study is underpowered. The sample size calculation provided suggests a power of 65.8% to detect a difference in pyelonephritis, and the confidence interval for the primary endpoint spans from a risk ratio of 0.4 to 4.8 – either of which would be a clinically important difference in risk. Further studies are required to confirm these findings.

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT01771432

Funding source
Industry & non-industry funded