Application of NGS Technique in Precise Diagnosis of Infectious Diseases

NCT ID: NCT03232242

Last Updated: 2017-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Next Generation Sequencing Infectious Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Next-generation sequencing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-hong Zhang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenhong Zhang, PhD,MD

Role: CONTACT

+86 21 52889999 ext. 8123

Jialin Jin, PhD,MD

Role: CONTACT

+86 15601957225

Facility Contacts

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Wenhong Zhang, PhD,MD

Role: primary

+86 21 52889999 ext. 8123

Other Identifiers

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KY2017-338

Identifier Type: -

Identifier Source: org_study_id

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