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.
Keywords: Acute respiratory infection; Multiplex PCR; Randomized controlled trials; mNGS.
【저자키워드】 Randomized controlled trials, Multiplex PCR, Acute respiratory infection, mNGS., 【초록키워드】 Treatment, SARS-CoV-2, Severe infection, Efficacy, Treatment outcome, clinical trial, Randomized controlled trials, Open-label, Prognosis, mechanical ventilation, Hospitalization, Multiplex PCR, diagnostic, Diagnosis, oxygen, clinical manifestations, Randomized, respiratory infection, ARI, outbreak, non-inferiority, Patient, pathway, Acute respiratory infection, incidence, multicenter, group, resource, Clinical diagnosis, primary endpoint, Consensus, Treatment strategies, Endpoint, two groups, both groups, Secondary endpoints, participant, alarm, secondary, event, enrolled, tested, include, reached, two group, receive, 1:1, in both groups, 【제목키워드】 Randomized controlled trial, Study protocol, severity,