NCT03884881

Second-generation Sequencing Guides the Treatment of Severe Pneumonia

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia
• Metagenomic Next Generation Sequencing

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	metagenomic next generation sequencing	Pathogens in the NGS group will be tested by NGS，then according the NGS results, adjust antibiotics
DIAGNOSTIC_TEST	Conventional pathogen detection	Morphological detection, microbial culture, nucleic acid amplification technology, serological pathogen antibody titer detection and specific pathogen PCR detection. Then, according to the pathogen results, adjust antibiotics
DRUG	Meropenem，Imipenem，Caspofene，Osstat	Meropenem，Imipenem，Caspofene，Osstat

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-03-21
• Last updated: 2019-03-21

Locations

1 site across 1 country: China