Dataset Information

Early identification and severity prediction of acute respiratory infection (ESAR): a study protocol for a randomized controlled trial.

ABSTRACT:

Background

The outbreak of SARS-CoV-2 at the end of 2019 sounded the alarm for early inspection on acute respiratory infection (ARI). However, diagnosis pathway of ARI has still not reached a consensus and its impact on prognosis needs to be further explored.

Methods

ESAR is a multicenter, open-label, randomized controlled, non-inferiority clinical trial on evaluating the diagnosis performance and its impact on prognosis of ARI between mNGS and multiplex PCR. Enrolled patients will be divided into two groups with a ratio of 1:1. Group I will be directly tested by mNGS. Group II will firstly receive multiplex PCR, then mNGS in patients with severe infection if multiplex PCR is negative or inconsistent with clinical manifestations. All patients will be followed up every 7 days for 28 days. The primary endpoint is time to initiate targeted treatment. Secondary endpoints include incidence of significant events (oxygen inhalation, mechanical ventilation, etc.), clinical remission rate, and hospitalization length. A total of 440 participants will be enrolled in both groups.

Discussion

ESAR compares the efficacy of different diagnostic strategies and their impact on treatment outcomes in ARI, which is of great significance to make precise diagnosis, balance clinical resources and demands, and ultimately optimize clinical diagnosis pathways and treatment strategies. Trial registration Clinicaltrial.gov, NCT04955756, Registered on July 9th 2021.

SUBMITTER: Yuan G

PROVIDER: S-EPMC9296892 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Publications

Early identification and severity prediction of acute respiratory infection (ESAR): a study protocol for a randomized controlled trial.

Yuan Guanmin G Wang Hongyu H Zhao Yuanhan Y Mao Enqiang E Li Mengjiao M Wang Ruilan R Zhou Fangqing F Jin Shanshan S Zhang Ziqiang Z Xu Ke K Xu Jinfu J Liang Shuo S Li Xiang X Jiang Lijing L Zhang Lu L Song Jieyu J Yang Tao T Guo Jinxin J Zhang Haocheng H Zhou Yang Y Wang Sen S Qiu Chao C Jiang Ning N Ai Jingwen J Wu Jing J Zhang Wenhong W

BMC infectious diseases 20220720 1

<h4>Background</h4>The outbreak of SARS-CoV-2 at the end of 2019 sounded the alarm for early inspection on acute respiratory infection (ARI). However, diagnosis pathway of ARI has still not reached a consensus and its impact on prognosis needs to be further explored.<h4>Methods</h4>ESAR is a multicenter, open-label, randomized controlled, non-inferiority clinical trial on evaluating the diagnosis performance and its impact on prognosis of ARI between mNGS and multiplex PCR. Enrolled patients wil ...[more]

PMID: 35858876

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Dataset Information

Early identification and severity prediction of acute respiratory infection (ESAR): a study protocol for a randomized controlled trial.

Background

Methods

Discussion

Publications

Early identification and severity prediction of acute respiratory infection (ESAR): a study protocol for a randomized controlled trial.

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