Background: Infectious morbidity is a cumulative function of recurrent events. Historically, data collection has depended on time-to-event analyses, variable definitions, and retrospective data. To better understand prevention strategies and infectious morbidity, we performed a prospective cohort study using standardized definitions and event-driven data, with novel analytic methods to characterize risks for recurrent events. Methods: Kidney recipients (KT) transplanted in 2012, who consented to data collection and phone calls every 3 mos, were assessed for development of specific infections. Demographic data, immunosuppression, rejection and graft outcomes were recorded. Infection rate was summarized by number of infections per person-year. Risk factors were evaluated with an extension of the Cox Model for recurrent events with robust variance estimates. Results: Median followup of 161 KT recipients was 20.5 mos. Median age was 53; 60% were male; 57% Caucasian. 41% had living donors and 59% deceased donors; 19% were HLA and/or ABO-incompatible. Immunosuppression included rituximab in 21% and belatacept in 16%; 98% received thymoglobulin. 155 (96%) were alive at last follow-up. Recurrent, serious infections were frequent. Analysis of event timing showed clustering of bloodstream, GI, and some viral infections (esp. BKV) early after KT. Infection rate per person-year was 0.28 for any virus (0.15 BKV, 0.12 CMV, 0.02 EBV). Bloodstream infections occurred at 0.06, respiratory infections at 0.11, GI infections at 0.28, and pyelonephritis at 0.09 per person-year. Belatacept was associated with increased risk for any viral infection (rate ratio 2.05, 95%CI: 1.29-3.26, p=0.002) and CMV (rate ratio 2.87, 95%CI: 1.38-5.98, p = 0.005). There was a trend towards lower risk for respiratory, any viral, and BKV infection with living donor transplants. Conclusions: Morbidity associated with recurrent infectious events was characterized in a prospective cohort study using novel methodology. This should inform development of better prevention strategies; e.g., receipt of belatacept may warrant enhanced methods to prevent viral infections.Studies using similar methods across centers will enable comparative effectiveness analyses in variable-risk transplant recipients.

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