儿童呼吸道感染实用适应性试验（PATRIC）临床注册方案。

Pragmatic Adaptive Trial for Respiratory Infection in Children (PATRIC) Clinical Registry protocol.

作者信息

Pavlos Rebecca, Bhuiyan Mejbah U, Jones Mark, Oakes Daniel, O'Brien Sharon, Borland Meredith L, Doyle Sarah, Richmond Peter, Martin Andrew C, Snelling Thomas L, Blyth Christopher C

机构信息

Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.

School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.

出版信息

BMJ Open. 2024 Jan 25;14(1):e074308. doi: 10.1136/bmjopen-2023-074308.

DOI:10.1136/bmjopen-2023-074308

PMID:38272557

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10824052/

Abstract

INTRODUCTION

Acute respiratory infections (ARI) are the most common cause of paediatric hospitalisation. There is an urgent need to address ongoing critical knowledge gaps in ARI management. The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) Clinical Registry will evaluate current treatments and outcomes for ARI in a variety of paediatric patient groups. The registry will provide a platform and data to inform a number of PATRIC clinical trials, testing various interventions in ARI treatment and management to optimise paediatric ARI care.

METHODS AND ANALYSIS

The PATRIC Clinical Registry is a single-centre, prospective observational registry recruiting from a tertiary paediatric Emergency Department in Western Australia. Through characterising demographic, clinical, treatment and outcome data, the PATRIC Clinical Registry will improve our understanding of antibiotic utilisation and ARI outcomes in children.

ETHICS AND DISSEMINATION

The PATRIC Clinical Registry is conducted in accordance with the Declaration of Helsinki, and the International Council for Harmonisation (ICH) Guidelines for Good Clinical Practice (CPMP/ICH/13595) July 1996. Approval is provided by the Child and Adolescent Health Service Human Research Ethics Committee (HREC). Study results will be communicated by presentation and publication (HREC: RGS0000003078.) TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000903189. UTN: U1111-1231-3365.

摘要

引言

急性呼吸道感染（ARI）是儿科住院最常见的原因。迫切需要解决ARI管理中持续存在的关键知识空白。儿童呼吸道感染实用适应性试验（PATRIC）临床登记将评估各种儿科患者群体中ARI的当前治疗方法和结果。该登记将提供一个平台和数据，为多项PATRIC临床试验提供信息，测试ARI治疗和管理中的各种干预措施，以优化儿科ARI护理。

方法与分析

PATRIC临床登记是一项单中心、前瞻性观察登记，从西澳大利亚一家三级儿科急诊科招募患者。通过对人口统计学、临床、治疗和结果数据进行特征分析，PATRIC临床登记将增进我们对儿童抗生素使用情况和ARI结果的了解。

伦理与传播

PATRIC临床登记按照《赫尔辛基宣言》以及国际协调理事会（ICH）1996年7月的《药物临床试验质量管理规范》（CPMP/ICH/13595）进行。该研究已获得儿童和青少年健康服务人类研究伦理委员会（HREC）的批准。研究结果将通过报告和发表进行交流（HREC：RGS0000003078）。试验注册号：澳大利亚新西兰临床试验注册中心（ANZCTR）：ACTRN12619000903189。UTN：U1111 - 1231 - 3365。