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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884881
Recruitment Status : Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pneumonia Metagenomic Next Generation Sequencing Diagnostic Test: metagenomic next generation sequencing Diagnostic Test: Conventional pathogen detection Drug: Meropenem,Imipenem,Caspofene,Osstat Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Second-generation Sequencing in the Treatment of Severe Pneumonia With Initial Treatment Failure
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
metagenomic next generation sequencing
Adjust medication for patients with severe pneumonia based on mNGS results
Diagnostic Test: metagenomic next generation sequencing
Pathogens in the NGS group will be tested by NGS,then according the NGS results, adjust antibiotics

Drug: Meropenem,Imipenem,Caspofene,Osstat
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.
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




Primary Outcome Measures :
  1. mortality [ Time Frame: 28 day ]
    Using the Kaplan-Meier method to analyze the differences in mortality between the two groups within 28 days


Secondary Outcome Measures :
  1. mechanical ventilation time [ Time Frame: 30 days ]
    According to the secondary result, comprehensively evaluate the two detection methods for the treatment of patients with severe pneumonia



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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。

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884881


Locations
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China, Hunan
Xiangya Hospital
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Xiangya Hospital of Central South University
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03884881    
Other Study ID Numbers: 81770080
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Meropenem
Imipenem
Anti-Bacterial Agents
Anti-Infective Agents