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Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection

NCT04217252 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-03-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical value of high throughput sequencing of infectious pathogens for patients with severe infection, and to establish foundation for high throughput sequencing to be the clinical routine infection pathogen examination. This study is a diagnostic study, and the sample size is 320 cases. 320 participants from the department of hematology and intensive care unit who meet the inclusion criteria are randomly divided into the control group and the experimental group with 160 cases in each group. Both the participants of the control group and the experimental group undergo routine clinical diagnosis methods and treatment. In addition, the participants of the experimental group are collected the samples including whole blood, cerebrospinal fluid or alveolar lavage fluid required for high throughput sequencing of infectious pathogens during sample collection for routine pathogenic examination of infection. The pathogen diagnosis rate and the diagnostic accuracy rate between the conventional infectious pathogen tests and the high throughput sequencing of infectious pathogens will be compared in the experimental group. By gathering statistics of consultation hours and cost efficiency, the effect of high throughput sequencing of infectious pathogens on the diagnosis and treatment efficiency of the experimental group and the control group will be compared, and through these indicators, clinical application value for the diagnosis of severe infection patients by high throughput sequencing of infectious pathogens can be evaluated.

Conditions

Interventions

DIAGNOSTIC_TEST

PMseqTM high-throughput sequencing technology

high throughput sequencing of infectious pathogens

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Lingxiao Jiang · Division of Laboratory Medicine, Zhujiang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-04-30
Completion
2022-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04217252 on ClinicalTrials.gov