Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Application of NGS Technique in Precise Diagnosis of Infectious Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03232242
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Collaborators:
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Children's Hospital of Fudan University
Information provided by (Responsible Party):
Wen-hong Zhang, Huashan Hospital

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.


Condition or disease Intervention/treatment
Next Generation Sequencing Infectious Disease Diagnostic Test: Next-generation sequencing

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Next Generation Sequencing Technique in Precise Diagnosis of Infectious Diseases
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

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


Primary Outcome Measures :
  1. Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of next-generation sequencing in the pathogen detection of infectious diseases [ Time Frame: 3 years ]
    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.).


Secondary Outcome Measures :
  1. Diagnostic value (sensitivity and sensibility, positive/negative predictive value) of traditional methods in the pathogen detection of infectious diseases [ Time Frame: 3 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that are highly suspected of infectious diseases, and they will be selected mainly from infectious diseases departments .
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232242


Contacts
Layout table for location contacts
Contact: Wenhong Zhang, PhD,MD +86 21 52889999 ext 8123 zhangwenhong@fudan.edu.cn
Contact: Jialin Jin, PhD,MD +86 15601957225 jinjialin2002@126.com

Locations
Layout table for location information
China, Shanghai
Huashan Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Wenhong Zhang, PhD,MD    +86 21 52889999 ext 8123    zhangwenhong@fudan.edu.cn   
Sponsors and Collaborators
Huashan Hospital
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Children's Hospital of Fudan University

Layout table for additonal information
Responsible Party: Wen-hong Zhang, Director, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03232242     History of Changes
Other Study ID Numbers: KY2017-338
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infection