Application of NGS Technique in Precise Diagnosis of Infectious Diseases

Application of Next Generation Sequencing Technique in Precise Diagnosis of Infectious Diseases

Infectious disease leads to deaths that accounted for more than 25% of all causes of human mortality. But the traditional microbiological diagnostic methods such as specimen culture are sometimes time-consuming, and have limited sensitivity. And some bacteria, anaerobes and viruses may be difficult to cultivate and isolation. Therefore, the accurate identification and rapid classification of pathogenic microorganisms is very important for the patient's precise diagnosis and timely treatment.

Small-scale studies on the diagnostic efficacy and prognosis of infection in the next generation have been shown to provide early diagnosis and targeted medication guidance for bloodstream infections and respiratory infections, but the larger-scale validation of next-generation sequencing Technology in the diagnosis and treatment of infectious diseases in the human body is relatively rare.

The purpose of this study is to provide rapid etiological diagnosis of patients by means of next-generation sequencing, to change the way of treatment of patients under the existing traditional pathogen detection by means of accurate description of pathogens and monitoring their dynamic changes, and to provide patients with more accurate treatment.

Study Overview

• Status: Unknown
• Conditions: Infectious Disease; Next Generation Sequencing
• Intervention / Treatment: Diagnostic test: Next-generation sequencing

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Jialin Jin, PhD,MD; Phone Number: +86 15601957225; Email: jinjialin2002@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients that are highly suspected of infectious diseases, and they will be selected mainly from infectious diseases departments .

Description

Inclusion Criteria:

• Patients are highly suspected of fever of unknown origin
• Patients are highly suspected of bloodstream infection
• Patients are highly suspected of respiratory infections
• Patients are highly suspected of central nervous system infection

Exclusion Criteria:

• Patients diagnosed as non-infectious diseases such as cancer and autoimmune diseases;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of next-generation sequencing in the pathogen detection of infectious diseases	We aim to collect samples from patients with fever, bacteremia and bloodstream infections, respiratory infections, central nervous system infections, and abscesses, including blood, cerebrospinal fluid, serous effusion, pus, sputum, alveolar lavage fluid, throat swab. Next-generation sequencing will be performed on the collected samples. Our analysis of the sequencing results will focus on the analysis and identification of pathogen genes and will compare the diagnostic performance of next-generation sequencing with conventional etiological diagnostic methods. We anticipate that next-generation sequencing in infectious patients will show a greater diagnostic value than the traditional methods (including culture, special pathogen serology, PCR detection of nucleic acids, etc.).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of traditional methods in the pathogen detection of infectious diseases	We aim to collect samples from patients with fever, bacteremia and bloodstream infections, respiratory infections, central nervous system infections, and abscesses, including blood, cerebrospinal fluid, serous effusion, pus, sputum, alveolar lavage fluid, throat swab. Traditional methods including culture, special pathogen serology, PCR detection of nucleic acids, etc, will be performed on the collected samples. Our analysis aims to study the diagnostic power of the traditional diagnostic methods in infectious diseases.	3 years

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Children's Hospital of Fudan University; Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2017
• Primary Completion (ANTICIPATED): July 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (ACTUAL): July 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: KY2017-338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No