Effect of Metagenomic Next-Generation Sequencing on Clinical Outcomes of Patients with Severe Community-Acquired Pneumonia in ICU: A Multicenter Randomized Controlled Trial
Abstract
BACKGROUND
Metagenomic 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 QUESTION
What is the impact on clinical outcomes of mNGS of BALF in ICU patients with SCAP?
STUDY DESIGN AND METHODS
A multicenter, randomized, open-label clinical trial was conducted in 10 ICUs. Patients were randomized in a 1:1 ratio to undergo BALF with the conventional microbiological tests (CMTs) only (CMT group) or both BALF with mNGS and CMTs (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.
RESULTS
A total of 349 patients were randomized between January 1, 2021, to November 18, 2022, of whom 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 that in the CMT group (10 d vs. 13 d, difference: -2.0 [95% CI = -3.0 to 0.0]). Similar results were obtained in the per-protocol analysis. The proportion of patients with clinical improvement within 14 d was significantly higher in the mNGS group (62.0%) than that in the CMT group (46.5%). There was no significant difference in other secondary outcomes.
CONCLUSION
MNGS combined with CMTs reduced the time to clinical…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 349 participants or records.
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