• Xiaojing Wu, Ting Sun, Hangyong He, Lihua Xing, Zhenshun Cheng, Shuang Geng, Dexiang Xu, Hong Luo, Cheng Chen, Mingyan Jiang, Guopeng Hou, Tianshu Zhai, Ying Cai, Yijie Liu, Junlu Li, Lan Ni, Xueying Li, Binbin Qu, Cheng Lei, Yang Wang, Zi Gu, Peng Zhang, Xu Huang, Min Li, Jingen Xia, Lian He, and Qingyuan Zhan.
• National Center for Respiratory Medicine; State Key Laboratory of Respiratory Health and Multimorbidity; National Clinical Research Center for Respiratory Diseases; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing; Department of Respiratory and Critical Care Medicine, Beijing.
• Chest. 2024 Jul 25.

BackgroundMetagenomic next-generation sequencing (mNGS) was previously established as a method that can increase the pathogen identification rate in patients with severe community-acquired pneumonia (SCAP).Research QuestionWhat is the impact on clinical outcomes of mNGS of BAL fluid (BALF) in patients with SCAP in the ICU?Study Design And MethodsA multicenter, randomized controlled, open-label clinical trial was conducted in 10 ICUs. Patients were randomized in a 1:1 ratio to undergo BALF assessment with conventional microbiological tests (CMTs) only (ie, the CMT group) or BALF assessment with both mNGS and CMTs (ie, the mNGS group). The primary outcome was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a six-category ordinal scale or discharge from the ICU, whichever occurred first.ResultsA total of 349 patients were randomized to treatment between January 1, 2021, and November 18, 2022; 170 were assigned to the CMT group and 179 to the mNGS group. In the intention-to-treat analysis, the time to clinical improvement was better in the mNGS group than in the CMT group (10 days vs 13 days; difference, -2.0 days; 95% CI, -3.0 to 0.0 days). Similar results were obtained in the per-protocol analysis. The proportion of patients with clinical improvement within 14 days was significantly higher in the mNGS group (62.0%) than in the CMT group (46.5%). There was no significant difference in other secondary outcomes.InterpretationCompared with the use of CMTs alone, mNGS combined with CMTs reduced the time to clinical improvement for patients with SCAP.Clinical Trial RegistrationChiCTR2000037894.Copyright © 2024. Published by Elsevier Inc.

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