NCT03884881: NGS

Second-generation Sequencing Guides the Treatment of Severe Pneumonia

Status unknown NA Last updated 21 March 2019

What this trial tests

NA trial testing metagenomic next generation sequencing in Pneumonia in 400 participants. Status unknown.

Timeline

1 January 2018

Primary endpoint
1 December 2019

1 December 2019

Quick facts

Lead sponsor	Xiangya Hospital of Central South University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	400
Start date	1 January 2018
Primary completion	1 December 2019
Estimated completion	1 December 2019
Sites	1 location across China

Drugs / interventions tested

• metagenomic next generation sequencing
• Conventional pathogen detection
• Meropenem，Imipenem，Caspofene，Osstat — full drug profile →

Conditions studied

• Pneumonia — all drugs for Pneumonia →
• Metagenomic Next Generation Sequencing — all drugs for Metagenomic Next Generation Sequencing →

Sponsor

Xiangya Hospital of Central South University

Who can join

Adults 18 to 85, any sex, with Pneumonia or Metagenomic Next Generation Sequencing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.