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Early identification and severity prediction of acute respiratory infection (ESAR): a study protocol for a randomized controlled trial.
Yuan, Guanmin; Wang, Hongyu; Zhao, Yuanhan; Mao, Enqiang; Li, Mengjiao; Wang, Ruilan; Zhou, Fangqing; Jin, Shanshan; Zhang, Ziqiang; Xu, Ke; Xu, Jinfu; Liang, Shuo; Li, Xiang; Jiang, Lijing; Zhang, Lu; Song, Jieyu; Yang, Tao; Guo, Jinxin; Zhang, Haocheng; Zhou, Yang; Wang, Sen; Qiu, Chao; Jiang, Ning; Ai, Jingwen; Wu, Jing; Zhang, Wenhong.
  • Yuan G; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Wang H; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Zhao Y; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Mao E; Departments of Emergency, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
  • Li M; Departments of Emergency, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
  • Wang R; Department of Critical Care Medicine, Shanghai General Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
  • Zhou F; Department of Critical Care Medicine, Shanghai General Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
  • Jin S; Department of Critical Care Medicine, Shanghai General Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
  • Zhang Z; Department of Infectious Disease, Tongji Hospital, School of Medicine of Tongji University, Shanghai, China.
  • Xu K; Department of Respiratory and Critical Care Medicine, Tongji Hospital, School of Medicine of Tongji University, Shanghai, China.
  • Xu J; Department of Infectious Disease, Tongji Hospital, School of Medicine of Tongji University, Shanghai, China.
  • Liang S; Department of Respiratory and Critical Care Medicine, Tongji Hospital, School of Medicine of Tongji University, Shanghai, China.
  • Li X; Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
  • Jiang L; Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
  • Zhang L; Department of Critical Care Medicine, Minhang Hospital, Fudan University, Shanghai, 201199, China.
  • Song J; Department of Critical Care Medicine, Minhang Hospital, Fudan University, Shanghai, 201199, China.
  • Yang T; Department of Critical Care Medicine, Minhang Hospital, Fudan University, Shanghai, 201199, China.
  • Guo J; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Zhang H; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Zhou Y; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Wang S; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Qiu C; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Jiang N; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Ai J; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Wu J; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China.
  • Zhang W; Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, No. 12 Middle Urumqi Road, Jing'an, Shanghai, 200040, China. jingwenai1990@126.com.
BMC Infect Dis ; 22(1): 632, 2022 Jul 20.
Article in English | MEDLINE | ID: covidwho-1935459
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 11. 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S12879-022-07552-7

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: BMC Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: S12879-022-07552-7