Metagenomic NGS for Diagnosis of Pneumonia

Status Not yet recruiting

Clinical Trial Summary

In this randomized controlled trial, we aim to evaluate the efficacy of incorporating mNGS in the management of pneumonia on efficiency and accuracy of causative pathogen identification, proportion of participants with effective antimicrobial therapy, length of hospitalization, and mortality.

Clinical Trial Description

This is an open-label, randomized, multi-center, phase 2 study that will evaluate the efficacy of incorporating mNGS in the management of severe pneumonia on accuracy and efficiency of achieving definite diagnosis of identifying causative pathogens of pneumonia, appropriate antimicrobial therapy and patient outcomes. The diagnosis of pneumonia requires radiological evidence of pneumonia and at least two of the following clinical criteria: new, or worsening cough, new or worsening expectoration of sputum, new or worsening dyspnea, hemoptysis, pleuritic chest pain, and fever (≥38.0°C). Severe pneumonia is defined as pneumonia with hypoxemia requiring orotracheal intubation and mechanical ventilation support. Written informed consent is needed from the eligible subjects or from their legal guardian at the time of recruitment. After completing informed consent, subjects will be randomized with a 1:1 allocation ratio via a web-based randomization system to receive standard of care (SOC) using culture and serology based work-up for pathogen detection or SOC with additional mNGS method using APGseq ® (Asia Pathogenomics, New Taipei City, Taiwan) for pathogen detection. The treatment for pneumonia is suggested following the Taiwan Guidelines for the Management of Pneumonia published in 2018. After randomization, the subjects will be followed until death, discharged from the hospital or 28 days after randomization whichever comes first. The total study duration is expected to be two years from the first subject enrolled to the final analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05979350
Study type	Interventional
Source	National Taiwan University Hospital
Contact	Sheng-Yuan Ruan, MD
Phone	886-2-23123456
Email	syruan@ntu.edu.tw
Status	Not yet recruiting
Phase	N/A
Start date	August 1, 2023
Completion date	July 31, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Completed	`NCT05815264` - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above	Phase 1
Recruiting	`NCT04589936` - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care	N/A
Completed	`NCT02905383` - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital	N/A
Terminated	`NCT03944551` - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa	N/A
Completed	`NCT06210737` - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years	Phase 4
Terminated	`NCT04660084` - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Withdrawn	`NCT05702788` - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)	Phase 2
Not yet recruiting	`NCT04171674` - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.	N/A
Active, not recruiting	`NCT03140163` - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]	N/A
Completed	`NCT02638649` - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed	`NCT02864420` - Hospitalization at Home: The Acute Care Home Hospital Program for Adults	N/A
Recruiting	`NCT02515565` - Physiotherapy in Patients Hospitalized Due to Pneumonia.	N/A
Completed	`NCT02105298` - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)	N/A
Completed	`NCT01446926` - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants	Phase 1
Completed	`NCT01399723` - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia	Phase 3
Completed	`NCT01416519` - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation	N/A
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT01416506` - Community-Acquired Pneumonia (CAP) Surveillance	N/A