Suspended

Metagenomic Sequencing for Severe Pneumonia Diagnosis

Study Aim

This study aims to evaluate how quickly metagenomic sequencing can accurately diagnose severe pneumonia by identifying the causative pathogens within 7 days.

What is being tested

Metagenomic next-generation sequencing

+ Standard work-up for pneumonia

Diagnostic Test

Who is being recruted

Disease+5

+ Infections

+ Lung Diseases

Over 18 Years

See all eligibility criteria

How is the trial designed

Diagnostic Study

Interventional

Study Start: August 2023

See protocol details

Summary

Principal SponsorNational Taiwan University Hospital

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 7, 2023

Actual date on which the first participant was enrolled.

This study seeks to explore a new way to diagnose and treat severe pneumonia, which is a serious lung infection that can cause breathing problems and requires intensive medical care. The focus is on using a cutting-edge technique called metagenomic next-generation sequencing (mNGS) to identify the germs causing the pneumonia more accurately and quickly. The study is important because it may help doctors choose better treatments faster, potentially improving the recovery chances for patients suffering from this severe condition. People eligible for the study have pneumonia confirmed by a chest scan and certain symptoms like cough, fever, or difficulty breathing. Participants in the study will be randomly assigned to two groups. One group will receive the usual diagnostic tests and treatments, while the other will have the same care with the addition of the mNGS method for identifying the infection-causing germs. This involves analyzing a sample to find the specific bacteria or viruses present. The study aims to see if using mNGS can improve the accuracy and speed of diagnosis and treatment. Participants will be monitored until they leave the hospital or for up to 28 days after joining the study, ensuring their health and recovery are closely followed. The study expects to last about two years, providing valuable insights into improving pneumonia care.

Official TitleImpact of Incorporating Metagenomic Next-generation Sequencing in the Management of Pneumonia on Diagnostic Efficiency and Outcomes: A Randomized Controlled Trial

NCT05979350

Principal SponsorNational Taiwan University Hospital

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

114 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DiseaseInfectionsLung DiseasesPathologic ProcessesPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsPathological Conditions, Signs and Symptoms

Criteria

Inclusion Criteria: 1. Presenting to the ICU with a diagnosis of pneumonia (fulfilled with both radiographic and clinical criteria) 2. Adults aged ≥18 years 3. Orotracheally intubated 4. ICU admission for \<24 hours 5. APACHE II score \<35 on ICU admission Exclusion Criteria: 1. Life expectancy below 4 weeks 2. With an existing directive to withhold life-sustaining treatment 3. Patients not willing or able to provide a lower respiratory tract sample at ICU admission 4. Previous work-up has identified specific pathogens which can account for the index event of pneumonia 5. Multiplex PCR or NGS testing has been done for pathogen detection before screening

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Subjects assigned to the mNGS group will receive etiology work-up followed the protocol used in the standard care group and additional mNGS testing for two specimen of mini-bronchoalveolar lavage and one specimen of blood samples retrieved at the same time of standard work-up.

Group II

Active Comparator

Endotracheal aspirates, blood samples, urine samples, and nasopharyngeal swabs were obtained from the patients as soon as possible after ICU admission. Bacterial culture was performed, with the use of standard techniques, on blood samples and endotracheal aspirates. Urine antigen detection was performed for detection of L. pneumophila and S. pneumoniae. A PCR assay was performed on nasopharyngeal swabs for the detection of influenza A and B viruses and SARS-CoV-2 viruses. Fungal or mycobacterial detections, and whether to use multiplex PCR for pathogen detection, such as the FilmArray system, were determined at the discretion of the physicians.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Taiwan University Hospital

Taipei, TaiwanOpen National Taiwan University Hospital in Google Maps

SuspendedOne Study Center