Second-generation Sequencing Guides the Treatment of Severe Pneumonia

Pneumonia Clinical Trial

— NGS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03884881
• Other study ID #: 81770080
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2018
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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?

Related Conditions & MeSH terms

• Metagenomic Next Generation Sequencing
• Pneumonia

Intervention

Diagnostic Test:
• metagenomic next generation sequencing
Pathogens in the NGS group will be tested by NGS,then according the NGS results, adjust antibiotics
• 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

Locations

Country	Name	City	State
China	Xiangya Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days	28 day
Secondary	mechanical ventilation time	According to the secondary result, comprehensively evaluate the two detection methods for the treatment of patients with severe pneumonia	30 days