Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Division of Urology and McMaster Pediatric Surgery Research Collaborative, McMaster University, Hamilton, Ontario, Canada.
J Urol. 2014 May;191(5 Suppl):1501-7. doi: 10.1016/j.juro.2013.10.033. Epub 2014 Mar 26.
We determined the feasibility of a clinical trial of continuous antibiotic prophylaxis to prevent urinary tract infections in children with prenatal hydronephrosis.
We piloted a blinded, randomized, placebo controlled study of the urinary tract infection rate in infants with grades III-IV prenatal hydronephrosis at our institution between August 2010 and June 2013. Study exclusion criteria were grades I/II prenatal hydronephrosis, vesicoureteral reflux, duplication anomalies and age at randomization greater than 5 months. Prospectively collected feasibility data were obtained on eligibility, enrollment status, adherence to followup schedule, and medication and protocol compliance.
Of 301 screened patients 220 (73.1%) were ineligible for analysis and 2 (1%) missed the randomization window. Of the remaining 81 (26.9%) eligible patients 46 were enrolled (56.8%), 29 refused (39.5%) and consent is pending in 1 (1.2%). Reasons for declining participation included parental preference for or against continuous antibiotic prophylaxis and a lack of interest in participating in clinical research. Of 46 enrolled patients 29 (63%) completed the trial, 12 (26.1%) are still in followup and 5 (10.9%) withdrew. Of the 314 medication logs dispensed 263 were returned for a 95% mean medication compliance rate.
Based on the results of our pilot study a realistic recruitment rate for this group of patients is established, making a definitive trial of this topic feasible. However, due to the low number of eligible patients multicenter collaboration is critical to address the effect of continuous antibiotic prophylaxis on the urinary tract infection rate in this population. After study enrollment high medication and followup compliance can be expected.
我们旨在确定针对产前肾积水患儿进行持续性抗生素预防以防止尿路感染的临床试验的可行性。
我们在本机构于 2010 年 8 月至 2013 年 6 月进行了一项 III-IV 级产前肾积水婴儿尿路感染率的盲法、随机、安慰剂对照研究。研究排除标准为 I/II 级产前肾积水、膀胱输尿管反流、重复畸形以及随机分组时年龄大于 5 个月。前瞻性收集了可行性数据，包括合格性、入组情况、对随访计划的依从性以及药物和方案依从性。
在筛查的 301 例患者中，有 220 例（73.1%）不符合分析条件，有 2 例（1%）错过了随机分组窗口。在剩余的 81 例（26.9%）合格患者中，有 46 例入组（56.8%），29 例拒绝（39.5%），1 例（1.2%）的同意仍在等待中。拒绝参与的原因包括父母对持续性抗生素预防的偏好、对持续性抗生素预防的偏好或反对以及对参与临床研究缺乏兴趣。在入组的 46 例患者中，有 29 例（63%）完成了试验，12 例（26.1%）仍在随访中，有 5 例（10.9%）退出。在分发的 314 份用药记录中，有 263 份被归还，平均药物依从率为 95%。
根据我们的初步研究结果，为该组患者建立了现实的招募率，使该主题的确定性试验成为可能。然而，由于合格患者人数较少，多中心合作对于解决该人群中持续性抗生素预防对尿路感染率的影响至关重要。在研究入组后，预计药物和随访的依从性较高。
