跳至主要内容
临床试验/NCT03884881
NCT03884881Unknown不适用

The Role of Second-generation Sequencing in the Treatment of Severe Pneumonia With Initial Treatment Failure

Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
mortality

研究概览

简要总结

Investigators plan to conduct the participants level, 1:1 randomized trial at the Central ICU and respiratory ICU of Xiangya Hospital in Changsha, China, from January 1, 2018 to December 31, 2019. Participants with initial diagnosis of severe pneumonia will be first treated with empiric therapy, after 48-72 hours, the participants's condition will be evaluated, and participants who will have been initially cured and died should be excluded.The participants who will have failed the initial treatment will be then randomly divided into two groups: the NGS group and the conventional treatment group. Bronchoalveolar lavage fluid will be taken by bedside bronchoscopy when the participants underwent nasal high-flow oxygen therapy, non-invasive ventilation, and invasive ventilation,or venous blood will be taken for examination. Participants in the NGS group will be tested for both NGS and conventional pathogens, however, the routine group will be only routinely tested. According to the pathogen results, participants with non-severe pneumonia will be excluded, and medication should be adjusted under the joint guidance of infectious and respiratory specialists. Then investigators will compare the first outcome: 28-day mortality, and secondary outcome: ICU hospitalization time, mechanical ventilation time, Hospitalization costs, antibiotic use costs, SOFA scores, CURB-65 scores, APACHE scores, and other clinical indicators.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with severe pneumonia between the ages of 18 and 85 years; the diagnosis of severe pneumonia is based on IDSA / ATS

排除标准

  • < 18 years old, received antibiotic treatment within 14 days before admission, suffering from severe immunosuppression, multi-drug resistance, refractory tuberculosis, end-stage renal disease or liver disease (uremia, advanced liver cancer), pregnancy. Besides, we need to rule out patients who have been improved, died, and abandoned during the initial treatment。

研究组 & 干预措施

metagenomic next generation sequencing

Other

Adjust medication for patients with severe pneumonia based on mNGS results

干预措施: metagenomic next generation sequencing (Diagnostic Test)

metagenomic next generation sequencing

Other

Adjust medication for patients with severe pneumonia based on mNGS results

干预措施: Meropenem,Imipenem,Caspofene,Osstat (Drug)

Conventional pathogen detection

Other

Blood, bronchoalveolar lavage fluid (BALF), bronchial secretions samples will be collected and microbiologically tested prior to initial empirical antibiotic use.

干预措施: Conventional pathogen detection (Diagnostic Test)

Conventional pathogen detection

Other

Blood, bronchoalveolar lavage fluid (BALF), bronchial secretions samples will be collected and microbiologically tested prior to initial empirical antibiotic use.

干预措施: Meropenem,Imipenem,Caspofene,Osstat (Drug)

结局指标

主要结局

mortality

时间窗: 28 day

Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days

次要结局

  • mechanical ventilation time(30 days)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验