背景:早期,快速,准确的病原体诊断可以帮助临床医生选择有针对性的治疗方案,从而改善预后并降低重症肺炎的死亡率。与传统的微生物测试相比,宏基因组下一代测序(mNGS)具有更高的灵敏度和更广泛的病原体谱。然而,基于mNGS的抗菌治疗程序对重症肺炎患者临床结局和成本效益的影响尚未评估.
方法:这是一个区域,多中心,打开,prospective,随机对照试验,以评估mNGS和传统测试方法的组合是否可以在中等成本效益的情况下降低28天呼叫原因死亡率。将从中国四家大型三级医院招募192名重症肺炎患者。将在所有患者中获得支气管肺泡灌洗液,并以1:1的比例随机分配到研究组(mNGS结合传统微生物测试)或对照组(仅传统微生物测试)。根据分析结果选择个体化抗菌治疗和策略。主要结果是28天全因死亡率。次要结局是ICU和住院时间(LOS),无呼吸机天数和无ICU天数,MNGS与传统微生物测试之间的一致性,MNGS和传统微生物检测的检出率,外出时间,从小组分配到开始治疗的时间,血管加压药支持的持续时间,抗感染方案的类型和持续时间,耐药细菌或真菌的来源,ICU费用。
结论:mNGS的临床益处是潜在显著的,但也应考虑其局限性。
背景:ChineseClinicalTrialRegistry.org,ChiCTR2300076853。2023年10月22日注册。
BACKGROUND: Early, rapid, and accurate pathogen diagnosis can help clinicians select targeted treatment options, thus improving prognosis and reducing mortality rates of severe pneumonia. Metagenomic next-generation sequencing (mNGS) has a higher sensitivity and broader pathogen spectrum than traditional microbiological tests. However, the effects of mNGS-based antimicrobial treatment procedures on clinical outcomes and cost-effectiveness in patients with severe pneumonia have not been evaluated.
METHODS: This is a regional, multi-center, open, prospective, randomized controlled trial to evaluate that whether the combination of mNGS and traditional testing methods could decrease 28-day call-cause mortality with moderate cost-effectiveness. A total of 192 patients with severe pneumonia will be recruited from four large tertiary hospitals in China. Bronchoalveolar lavage fluid will be obtained in all patients and randomly assigned to the study group (mNGS combined with traditional microbiological tests) or the control group (traditional microbiological tests only) in a 1:1 ratio. Individualized antimicrobial treatment and strategy will be selected according to the analysis results. The primary outcome is 28-day all-cause mortality. The secondary outcomes are ICU and hospital length of stay (LOS), ventilator-free days and ICU-free days, consistency between mNGS and traditional microbiological tests, detective rate of mNGS and traditional microbiological tests, turn-out time, time from group allocation to start of treatment, duration of vasopressor support, types and duration of anti-infective regimens, source of drug-resistant bacteria or fungi, and ICU cost.
CONCLUSIONS: The clinical benefits of mNGS are potentially significant, but its limitations should also be considered.
BACKGROUND: ChineseClinicalTrialRegistry.org, ChiCTR2300076853. Registered on 22 October 2023.