Cranberry syrup vs trimethoprim in the prophylaxis of recurrent urinary tract infections among children: a controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
J. Uberos, M. Nogueras-Ocaña, V. Fernández-Puentes, R. Rodríguez-Belmonte, E. Narbona-López, A. Molina-Carballo, A. Muňoz-Hoyos
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引用次数: 16

Abstract

Correspondence: Jose Uberos Paediatric Clinical Management Unit, San Cecilio University Clinical Hospital, Avda de Madrid s/n, Granada, Spain Phone +34 9 5802 3411 Fax +34 958246661 Email juberos@ugr.es Objectives: The present study forms part of the ISRCTN16968287 clinical assay. The objective of this study was to determine the effectiveness of cranberry syrup in the prophylaxis of recurrent urinary tract infection (UTI). Design: Phase III randomized clinical trial. Setting: The study was conducted at the San Cecilio Clinical Hospital (Granada, Spain). Participants: A total of 192 patients were recruited. The subjects were aged between 1 month and 13 years. Criteria for inclusion were a background of recurrent UTI (more than two episodes of infection in the last 6 months), associated or otherwise with vesicoureteral reflux of any degree, or renal pelvic dilatation associated with UTI. Criteria for exclusion from recruitment to the study included the co-existence of UTI with other infectious diseases or with metabolic diseases, chronic renal insufficiency, and the presence of allergy or intolerance to any of the components of cranberry syrup or trimethoprim. Primary outcome measures: The primary objective was to determine the risk of UTI associated with each intervention. Results: Of the 198 patients initially eligible, 192 were finally included in the study to receive either cranberry syrup or trimethoprim. UTI was observed in 47 patients, 17 of whom were males and 30 females. We recruited 95 patients diagnosed with recurrent UTI on entry; during follow-up, 26 patients had a UTI (27.4%, 95% CI: 18.4%–36.3%). Six patients (6.3%) were male and 20 (21.1%) were female. Eighteen patients (18.9% of the total, 95% CI: 11%–26.3%) receiving trimethoprim had a UTI and eight patients (8.4% of the total, 95% CI: 2.8%–13.9%) were given cranberry. Sixty-six percent of the episodes of UTI recurrence were caused by Escherichia coli, with no significant differences being found between the two treatment branches. No differences were observed between the two treatment branches in the rate of resistance to antibiotics. Conclusion: Our study confirms that cranberry syrup is a safe treatment for the pediatric population. Cranberry prophylaxis has noninferiority with respect to trimethoprim in recurrent UTI. (European Clinical Trials Registry EuDract 2007-004397-62) (ISRCTN16968287).
蔓越莓糖浆与甲氧苄啶预防儿童复发性尿路感染的对照试验
通讯:Jose Uberos儿科临床管理部门,圣塞西利奥大学临床医院,Avda de Madrid s/n,格拉纳达,西班牙电话+34 9 5802 3411传真+34 958246661电子邮件juberos@ugr.es目的:本研究是ISRCTN16968287临床试验的一部分。本研究的目的是确定蔓越莓糖浆在预防复发性尿路感染(UTI)的有效性。设计:III期随机临床试验。背景:研究在San Cecilio临床医院(西班牙格拉纳达)进行。参与者:共招募192名患者。受试者年龄在1个月至13岁之间。纳入标准为尿路感染复发背景(过去6个月内感染超过两次),与膀胱输尿管任何程度的反流相关或其他相关,或与尿路感染相关的肾盆腔扩张。排除纳入研究的标准包括尿路感染与其他感染性疾病或代谢性疾病共存,慢性肾功能不全,以及对蔓越莓糖浆或甲氧苄氨嘧啶的任何成分过敏或不耐受。主要结局指标:主要目的是确定与每种干预措施相关的尿路感染风险。结果:在198名最初符合条件的患者中,192名最终被纳入研究,接受蔓越莓糖浆或甲氧苄氨嘧啶。47例患者出现尿路感染,其中男性17例,女性30例。我们招募了95名入院时被诊断为复发性尿路感染的患者;随访期间,26例患者出现尿路感染(27.4%,95% CI: 18.4% ~ 36.3%)。男性6例(6.3%),女性20例(21.1%)。接受甲氧苄氨嘧啶治疗的18名患者(占总数的18.9%,95% CI: 11%-26.3%)有尿路感染,8名患者(占总数的8.4%,95% CI: 2.8%-13.9%)接受蔓越莓治疗。66%的尿路感染复发是由大肠杆菌引起的,两种治疗方法之间没有显著差异。两种治疗分支对抗生素的耐药率没有差异。结论:我们的研究证实,蔓越莓糖浆是一种安全的治疗儿科人群。对于复发性尿路感染,蔓越莓预防与甲氧苄氨嘧啶相比无劣效性。(European Clinical Trials Registry euddraft 2007-004397-62) (ISRCTN16968287)。
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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