Application of NGS Technique in Precise Diagnosis of Infectious Diseases

NCT03232242 | Unknown DMC

• 1 other identifier: KY2017-338
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Next Generation Sequencing; Infectious Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of traditional methods in the pathogen detection of infectious diseases

  3 years

Interventions

Next-generation sequencing DIAGNOSTIC_TEST

To provide rapid etiological diagnosis of patients by means of next-generation sequencing.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: collaborator
• Children's Hospital of Fudan University: collaborator

Study Sites (1)

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (1)

• Fu Z, Ai J, Zhang H, Cui P, Xu T, Zhang Y, Zhang Y, Wu H, Shen A, Lin K, Zhang M, Qiu C, Jiang N, Zhou Y, Zhang W. Pathogen quantitative efficacy of different spike-in internal controls and clinical application in central nervous system infection with metagenomic sequencing. Microbiol Spectr. 2023 Dec 12;11(6):e0113923. doi: 10.1128/spectrum.01139-23. Epub 2023 Nov 20.

  PMID: 37982612 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wenhong Zhang, PhD,MD

CONTACT

+86 21 52889999; zhangwenhong@fudan.edu.cn

Jialin Jin, PhD,MD

CONTACT

+86 15601957225; jinjialin2002@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)