Second-generation Sequencing Guides the Treatment of Severe Pneumonia

NCT03884881 | Unknown DMC

• 1 other identifier: 81770080
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Metagenomic Next Generation Sequencing

Outcome Measures

Primary Outcomes (1)

• mortality

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

  28 day

Secondary Outcomes (1)

• mechanical ventilation time

  30 days

Study Arms (2)

metagenomic next generation sequencing

OTHER

Adjust medication for patients with severe pneumonia based on mNGS results

Diagnostic Test: metagenomic next generation sequencing; Drug: Meropenem，Imipenem，Caspofene，Osstat

Conventional pathogen detection

OTHER

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; Drug: Meropenem，Imipenem，Caspofene，Osstat

Interventions

metagenomic next generation sequencing DIAGNOSTIC_TEST

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

metagenomic next generation sequencing

Conventional pathogen detection 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

Conventional pathogen detection

Meropenem，Imipenem，Caspofene，Osstat DRUG

Meropenem，Imipenem，Caspofene，Osstat

Conventional pathogen detection; metagenomic next generation sequencing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with severe pneumonia between the ages of 18 and 85 years; the diagnosis of severe pneumonia is based on IDSA / ATS

You may not qualify if:

• \< 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。

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410008, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 21, 2019
• Study Start: January 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 21, 2019

Record last verified: 2018-12

Locations

CN (1)