Second-generation Sequencing Guides the Treatment of Severe Pneumonia

Not Applicable

• Conditions: Pneumonia; Metagenomic Next Generation Sequencing
• Interventions: Diagnostic Test: Conventional pathogen detection; Diagnostic Test: metagenomic next generation sequencing; Drug: Meropenem，Imipenem，Caspofene，Osstat

• Registration Number: NCT03884881
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-12
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Study First Posted: 2019-03-21
• Last Update Posted: 2019-03-21
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• < 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。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metagenomic next generation sequencing	Meropenem，Imipenem，Caspofene，Osstat	Adjust medication for patients with severe pneumonia based on mNGS results
Conventional pathogen detection	Conventional pathogen detection	Blood, bronchoalveolar lavage fluid (BALF), bronchial secretions samples will be collected and microbiologically tested prior to initial empirical antibiotic use.
Conventional pathogen detection	Meropenem，Imipenem，Caspofene，Osstat	Blood, bronchoalveolar lavage fluid (BALF), bronchial secretions samples will be collected and microbiologically tested prior to initial empirical antibiotic use.
metagenomic next generation sequencing	metagenomic next generation sequencing	Adjust medication for patients with severe pneumonia based on mNGS results

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
mechanical ventilation time	30 days	According to the secondary result, comprehensively evaluate the two detection methods for the treatment of patients with severe pneumonia

Trial Locations

Locations (1)

Xiangya Hospital; 🇨🇳 Changsha, Hunan, China