Second-generation Sequencing Guides the Treatment of Severe Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumonia Metagenomic Next Generation Sequencing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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metagenomic next generation sequencing

Adjust medication for patients with severe pneumonia based on mNGS results

Group Type OTHER

metagenomic next generation sequencing

Intervention Type DIAGNOSTIC_TEST

Pathogens in the NGS group will be tested by NGS，then according the NGS results, adjust antibiotics

Meropenem，Imipenem，Caspofene，Osstat

Intervention Type DRUG

Meropenem，Imipenem，Caspofene，Osstat

Conventional pathogen detection

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

Group Type OTHER

Conventional pathogen detection

Intervention Type DIAGNOSTIC_TEST

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

Meropenem，Imipenem，Caspofene，Osstat

Intervention Type DRUG

Meropenem，Imipenem，Caspofene，Osstat

Interventions

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metagenomic next generation sequencing

Pathogens in the NGS group will be tested by NGS，then according the NGS results, adjust antibiotics

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Meropenem，Imipenem，Caspofene，Osstat

Intervention Type DRUG

Eligibility Criteria

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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。

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No