三种不同短期疗程抗生素方案与单次磷霉素治疗成人女性单纯性下尿路感染的临床疗效和细菌学清除率（SCOUT 研究）：一项随机临床试验研究方案。

Clinical effectiveness and bacteriological eradication of three different Short-COurse antibiotic regimens and single-dose fosfomycin for uncomplicated lower Urinary Tract infections in adult women (SCOUT study): study protocol for a randomised clinical trial.

机构信息

Institut de Recerca en Atencio Primaria Jordi Gol, Barcelona, Catalonia, Spain.

UICEC de IDIAP Jordi Gol-Plataforma ScREN, Barcelona, Catalonia, Spain.

出版信息

BMJ Open. 2021 Nov 25;11(11):e055898. doi: 10.1136/bmjopen-2021-055898.

DOI:10.1136/bmjopen-2021-055898

PMID:34824124

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8627395/

Abstract

INTRODUCTION

Uncomplicated lower urinary tract infections (uLUTI) are a common problem in primary care. Current local guidelines recommend the use of a single 3 g dose of fosfomycin. However, most general practitioners (GP) prefer short-course therapies to single-dose therapy. No study has compared head-to-head short-course antimicrobial agents for uLUTIs. Therefore, the aim of this randomised clinical trial is to compare three different short-course antibiotic therapies with a single-dose of fosfomycin for these infections.

METHODS AND ANALYSIS

This will be a pragmatic, multicentre, parallel group, open trial. Women aged 18 or older and with symptoms of uLUTI and a positive urine dipstick analysis will be randomised to one of the following four groups: a single dose of 3 g of fosfomycin, 2 days of 3 g of fosfomycin o.d., 3 days of pivmecillinam 400 mg three times per day (t.i.d) or 5 days of nitrofurantoin 100 mg t.i.d. A total sample of 1120 patients was calculated. The primary endpoint is clinical effectiveness at day 7, defined as cure of symptoms reported by the patients in a diary including four symptoms: dysuria, urgency, frequency and suprapubic pain, which will be scored on a 4-point severity scale (not present/mild/moderate/severe). Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed. If positive, antibiograms for the three antibiotics studied will be performed. Bacterial eradication will be measured at days 14 and 28.

ETHICS AND DISSEMINATION

The study was approved by the Ethical Board of IDIAP Jordi Gol (reference number: 21/173-AC) and Spanish Agency of Medicines and Medical Devices. The findings of this trial will be disseminated through research conferences and peer-review journals.

TRIAL REGISTRATION NUMBER

NCT04959331; EudraCT Number: 2021-001332-26.

TIME SCHEDULE

January 2022 to April 2023.

摘要

简介

单纯性下尿路感染（uLUTI）是初级保健中的常见问题。目前的本地指南建议使用单次 3 克剂量的磷霉素。然而，大多数全科医生（GP）更喜欢短程治疗而不是单剂量治疗。没有研究比较过针对 uLUTIs 的头对头短程抗菌药物。因此，本随机临床试验的目的是比较三种不同的短程抗生素治疗与单次磷霉素治疗这些感染。

方法和分析

这将是一项实用的、多中心、平行组、开放性试验。年龄在 18 岁或以上、有 uLUTI 症状和尿试纸分析阳性的女性将被随机分配到以下四组之一：单次 3 克磷霉素、2 天 3 克磷霉素每天一次（o.d.）、3 天 400 毫克匹美西林每天三次（t.i.d.）或 5 天 100 毫克呋喃妥因每天三次（t.i.d.）。计算出总共需要 1120 名患者。主要终点是第 7 天的临床疗效，定义为患者在日记中报告的症状治愈，包括四个症状：尿痛、尿急、尿频和耻骨上疼痛，将按 4 分严重程度量表（无/轻度/中度/重度）进行评分。随访安排在第 7 天（电话）、第 14 天和第 28 天，以评估病情进展。将在三次现场访问中采集尿液样本并进行尿液培养。如果阳性，将对三种研究用抗生素进行药敏试验。细菌清除率将在第 14 天和第 28 天进行测量。