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Second-generation Sequencing Guides the Treatment of Severe Pneumonia (NGS)

Primary Purpose

Pneumonia, Metagenomic Next Generation Sequencing

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
metagenomic next generation sequencing
Conventional pathogen detection
Meropenem,Imipenem,Caspofene,Osstat
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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。

Sites / Locations

  • Xiangya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

metagenomic next generation sequencing

Conventional pathogen detection

Arm Description

Adjust medication for patients with severe pneumonia based on mNGS results

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2019
Last Updated
March 20, 2019
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT03884881
Brief Title
Second-generation Sequencing Guides the Treatment of Severe Pneumonia
Acronym
NGS
Official Title
The Role of Second-generation Sequencing in the Treatment of Severe Pneumonia With Initial Treatment Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Metagenomic Next Generation Sequencing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metagenomic next generation sequencing
Arm Type
Other
Arm Description
Adjust medication for patients with severe pneumonia based on mNGS results
Arm Title
Conventional pathogen detection
Arm Type
Other
Arm Description
Blood, bronchoalveolar lavage fluid (BALF), bronchial secretions samples will be collected and microbiologically tested prior to initial empirical antibiotic use.
Intervention Type
Diagnostic Test
Intervention Name(s)
metagenomic next generation sequencing
Intervention Description
Pathogens in the NGS group will be tested by NGS,then according the NGS results, adjust antibiotics
Intervention Type
Diagnostic Test
Intervention Name(s)
Conventional pathogen detection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Meropenem,Imipenem,Caspofene,Osstat
Intervention Description
Meropenem,Imipenem,Caspofene,Osstat
Primary Outcome Measure Information:
Title
mortality
Description
Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days
Time Frame
28 day
Secondary Outcome Measure Information:
Title
mechanical ventilation time
Description
According to the secondary result, comprehensively evaluate the two detection methods for the treatment of patients with severe pneumonia
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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。
Facility Information:
Facility Name
Xiangya Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China

12. IPD Sharing Statement

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Second-generation Sequencing Guides the Treatment of Severe Pneumonia

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