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

NCT04217252 | Withdrawn

• 1 other identifier: 20191230
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Infection

Keywords

severe infection; high throughput sequencing; infectious pathogen

Outcome Measures

Primary Outcomes (2)

• pathogen diagnosis rate

  probability of pathogens detected

  through study completion, an average of half a year

• the diagnostic accuracy rate

  probability of diagnosing correctly for high throughput sequencing of infectious pathogen

  through study completion, an average of half a year

Secondary Outcomes (2)

• money spent by participant

  through study completion, an average of half a year

• consultation hours

  through study completion, an average of half a year

Other Outcomes (5)

• the amount and type of antibiotics used

  through study completion, an average of half a year

• 28-day mortality

  through study completion, an average of half a year

• in-hospital mortality

  through study completion, an average of half a year

Study Arms (2)

the experimental group

EXPERIMENTAL

high throughput sequencing of infectious pathogens

Diagnostic Test: PMseqTM high-throughput sequencing technology

the control group

NO INTERVENTION

no intervention

Interventions

PMseqTM high-throughput sequencing technology DIAGNOSTIC_TEST

high throughput sequencing of infectious pathogens

the experimental group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 14 years old, male or female
• Body temperature \> 38 ℃
• Newly admitted patients
• The clinician judges that the patient may be infected, and need to undergo the infection pathogen tests
• The patients volunteer to participate in this study and sign informed consent form

You may not qualify if:

• The patients who can't cooperate

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Conditions

Infections

Study Officials

• Lingxiao Jiang

  Division of Laboratory Medicine, Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Technologist

Model Details: The 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. 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.

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 3, 2020
• Study Start: September 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 1 year after publication
• Access Criteria: Related researchers