Quinolone prophylaxis for the prevention of BK virus infection in kidney transplantation: study protocol for a randomized controlled trial.
Humar A, Gill J, et al.Trials 2013; 14: 185.
Aims
To assess the efficacy, safety and feasibility of a 3 month course of levofloxacin in kidney transplant recipients.
Interventions
Patients will be administered with either quinolone antibiotic levofloxacin or placebo.
Participants
154 kidney transplant recipients.
Outcomes
The primary outcome is the time to occurrence of BK viruria within the first year post-transplantation. Secondary safety outcomes include the incidence and type of all adverse events, incidence of acute rejection, microbiologically confirmed Clostridium difficile-associated diarrhoea, incidence of other infections, quinolone resistance where quinolone would have been a therapeutic option, effect of levofloxacin on immunosuppressive drug doses and blood levels, transplant failure and mortality.
Follow-up
1 year.
CET Conclusions
This study protocol outlines a double-blind, placebo controlled randomised controlled pilot study of levofloxacin as prophylaxis against BK virus in renal transplant recipients. The trial addresses an important issue in renal transplantation, as there is no universally recommended treatment for BK nephropathy (other than reduction of immunosuppression) and no validated strategy prophylaxis. This is a well-designed pilot study, which may prove very important. It will be particularly interesting to see whether there is a rebound of BK virus infection once prophylaxis stops at 3 months post-transplant.
Quality notes
This is a protocol, quality assessment is not appropriate.
Trial registration
ClinicalTrials.gov - NCT01353339