Application of NGS Technique in Precise Diagnosis of Infectious Diseases

Infectious Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03232242
• Other study ID #: KY2017-338
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2017
• Last updated: July 25, 2017
• Start date: August 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2017
• Source: Huashan Hospital
• Contact: Wenhong Zhang, PhD,MD
• Phone: +86 21 52889999
• Email: zhangwenhong[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease
• Next Generation Sequencing

Intervention

Diagnostic Test:
• Next-generation sequencing
To provide rapid etiological diagnosis of patients by means of next-generation sequencing.

Locations

Country	Name	City	State
China	Huashan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Huashan Hospital	Children's Hospital of Fudan University, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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