Published in:
Open Access
01-12-2022 | Polymerase Chain Reaction | Study protocol
Early identification and severity prediction of acute respiratory infection (ESAR): a study protocol for a randomized controlled trial
Authors:
Guanmin Yuan, Hongyu Wang, Yuanhan Zhao, Enqiang Mao, Mengjiao Li, Ruilan Wang, Fangqing Zhou, Shanshan Jin, Ziqiang Zhang, Ke Xu, Jinfu Xu, Shuo Liang, Xiang Li, Lijing Jiang, Lu Zhang, Jieyu Song, Tao Yang, Jinxin Guo, Haocheng Zhang, Yang Zhou, Sen Wang, Chao Qiu, Ning Jiang, Jingwen Ai, Jing Wu, Wenhong Zhang
Published in:
BMC Infectious Diseases
|
Issue 1/2022
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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.