Arreola-Guerra José M, Rosado-Canto Rodrigo, Alberú Josefina, Maravilla Ernesto, Torres-González Pedro, Criollo Elia, Pérez Maria, Mancilla Eduardo, Arvizu Mauricio, Morales-Buenrostro Luis Eduardo, Vilatobá-Chapa Mario, Sifuentes-Osornio José
Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, México.
Department of Transplantation, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, México.
Transpl Infect Dis. 2018 Oct;20(5):e12980. doi: 10.1111/tid.12980. Epub 2018 Sep 10.
The aim of this controlled clinical trial was to evaluate the efficacy and safety of fosfomycin trometamol (FOS) in urinary tract infection (UTI) prophylaxis during the first 6 months after renal transplant (RT).
The intervention group received 3 g of FOS PO every 10 days and trimethoprim-sulfamethoxazole (TMP-SMX, 160/800 mg) three times per week (Group 1), whereas the control group received TMP-SMX (160/800 mg) daily (Group 2). The outcomes were the time until the first UTI (symptomatic infection or asymptomatic bacteriuria (>10 CFU/mL)) and the incidence of UTI during the first 6 months post RT. Intermediate analysis was conducted after one-half of the estimated sample size of patients was enrolled.
The recruitment of patients was stopped after the intermediate analysis due showed no emerging trends or reasonable chance of demonstrating benefit. Sixty-seven patients were included (32 in Group 1 and 35 in Group 2). The UTI incidence (40.6% vs 42.8%, P = 0.85) and time until the first episode were similar between the groups (log rank, P = 0.862). UTI due to Klebsiella spp. was observed in both groups at equal rates (25% vs 20%, P = 0.62), episodes due to Escherichia coli were less frequent in Group 1 (12.5% vs 34.2%, P = 0.04), and Enterococcus faecalis infection only occurred in Group 2 (n = 4). Resistance to FOS was observed for Klebsiella spp.; in contrast, E. coli and E. faecalis were susceptible.
The addition of FOS to TMP-SMX was not beneficial for the prevention of UTI after RT in our setting. (ClinicalTrials.gov, NCT01820897).
这项对照临床试验的目的是评估磷霉素氨丁三醇（FOS）在肾移植（RT）后前6个月预防尿路感染（UTI）的疗效和安全性。
干预组每10天口服3克FOS，每周三次服用甲氧苄啶-磺胺甲恶唑（TMP-SMX，160/800毫克）（第1组），而对照组每天服用TMP-SMX（160/800毫克）（第2组）。观察指标为首次发生UTI（有症状感染或无症状菌尿（>10⁵CFU/mL））的时间以及RT后前6个月内UTI的发生率。在纳入估计样本量一半的患者后进行中期分析。
中期分析显示无明显趋势或显示获益的合理可能性后，停止患者招募。共纳入67例患者（第1组32例，第2组35例）。两组的UTI发生率（40.6%对42.8%，P = 0.85）和首次发作时间相似（对数秩检验，P = 0.862）。两组中肺炎克雷伯菌属所致UTI的发生率相同（25%对20%，P = 0.62），第1组大肠埃希菌所致发作较少见（12.5%对34.2%，P = 0.04），粪肠球菌感染仅发生在第2组（n = 4）。观察到肺炎克雷伯菌属对FOS耐药；相反，大肠埃希菌和粪肠球菌敏感。
在我们的研究中，FOS联合TMP-SMX对RT后预防UTI并无益处。（ClinicalTrials.gov，NCT01820897）
