Unit of Infectious Diseases, Hospital Universitario "12 de Octubre", Instituto de Investigación Hospital "12 de Octubre" (i+12), School of Medicine, Universidad Complutense, Madrid, Spain.
Department of Nephrology, Hospital Universitario "12 de Octubre", Instituto de Investigación Hospital "12 de Octubre" (i+12), School of Medicine, Universidad Complutense, Madrid, Spain.
Am J Transplant. 2016 Oct;16(10):2943-2953. doi: 10.1111/ajt.13829. Epub 2016 May 23.
The indication for antimicrobial treatment of asymptomatic bacteriuria (AB) after kidney transplantation (KT) remains controversial. Between January 2011 and December 2013, 112 KT recipients that developed one episode or more of AB beyond the second month after transplantation were included in this open-label trial. Participants were randomized (1:1 ratio) to the treatment group (systematic antimicrobial therapy for all episodes of AB occurring ≤24 mo after transplantation [53 patients]) or control group (no antimicrobial therapy [59 patients]). Systematic screening for AB was performed similarly in both groups. The primary outcome was the occurrence of acute pyelonephritis at 24-mo follow-up. Secondary outcomes included lower urinary tract infection, acute rejection, Clostridium difficile infection, colonization or infection by multidrug-resistant bacteria, graft function and all-cause mortality. There were no differences in the primary outcome in the intention-to-treat population (7.5% [4 of 53] in the treatment group vs. 8.4% [5 of 59] in the control group; odds ratio [OR] 0.88, 95% confidence interval [CI] 0.22-3.47) or the per-protocol population (3.8% [1 of 26] in the treatment group vs. 8.0% [4 of 50] in the control group; OR 0.46, 95% CI 0.05-4.34). Moreover, we found no differences in any of the secondary outcomes. In conclusion, systematic screening and treatment of AB beyond the second month after transplantation provided no apparent benefit among KT recipients (NCT02373085).
肾移植(KT)后无症状菌尿(AB)的抗菌治疗指征仍存在争议。在 2011 年 1 月至 2013 年 12 月期间,纳入了 112 例在移植后第二个月后发生一次或多次 AB 的 KT 受者进行本项开放标签试验。参与者按照 1:1 的比例随机分为治疗组(对所有发生在移植后≤24 个月的 AB 发作进行系统抗菌治疗[53 例])或对照组(无抗菌治疗[59 例])。两组均进行系统的 AB 筛查。主要结局是在 24 个月随访时发生急性肾盂肾炎的情况。次要结局包括下尿路感染、急性排斥反应、艰难梭菌感染、多药耐药菌定植或感染、移植物功能和全因死亡率。意向治疗人群中主要结局无差异(治疗组为 7.5%[4/53],对照组为 8.4%[5/59];比值比[OR]0.88,95%置信区间[CI]0.22-3.47)或符合方案人群中(治疗组为 3.8%[1/26],对照组为 8.0%[4/50];OR0.46,95%CI0.05-4.34)。此外,我们在任何次要结局中均未发现差异。综上,在 KT 受者中,对移植后第二个月后发生的 AB 进行系统筛查和治疗似乎没有明显获益(NCT02373085)。