Transplant Trial Watch

Perioperative fosfomycin disodium prophylaxis against urinary tract infection in renal transplant recipients: a randomized clinical trial.

Rosado-Canto, R. et al.

Nephrology Dialysis Transplantation [record in progress].


Aims
The primary aim of this study was to determine the ability of Fosfomycin (FOS) to effectively and safely prevent episodes of symptomatic urinary tract infection (UTI) and asymptomatic bacteriuria (AB) in renal transplant recipients (RTRs) in comparison to the standard trimethoprim/sulfamethoxazole prophylaxis during the first seven weeks post-transplant.

Interventions
Patients were randomized in a 1:1 ratio to either receive FOS or placebo (0.9% saline solution).

Participants
82 renal transplant recipients.

Outcomes
The primary outcomes measured included the average number of symptomatic UTI or AB episodes in patients in the first 7 weeks post-transplant. The secondary outcomes included time to the first symptomatic UTI or AB episode; the incidence of symptomatic UTI, bacteremia, AB, infection (Clostridioides difficile), pyelonephritis, multidrug-resistant bacterial infection and symptomatic UTI hospitalization. Adverse events associated with volume overload, hematological and gastrointestinal events, acute rejection rate, patient death and graft loss, were assessed as safety outcomes.

Follow-up
7 weeks

CET Conclusions
This single-centre double-blind placebo-controlled trial investigates the use of Fosfomycin prophylaxis (given pre-operatively, and at catheter and stent removal) in renal transplant recipients. The authors report significantly lower mean numbers of infections and less symptomatic bacteriuria in the Fosfomycin group, with no difference in adverse event rates. The study is very well designed and reported, with adequate blinding, allocation concealment and use of a placebo. Outcome definitions are clear and robust. Fosfomycin certainly appears to demonstrate benefit in the context of this centre’s antibiotic, catheter and stent protocols – it would be interesting to see if this generalizes to other centre’s varying protocols.

Jadad score
5

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NTC03235947

Funding source
Industry funded