NCT04955756

Brief Summary

Early identification and Severity prediction of Acute Respiratory infectious disease has become a top priority for clinicians at department of infectious and respiratory diseases after COVID-19 broke out. This is a multicenter, prospective, and randomized study, which aims to figure out the best way of early identification and severity prediction of acute respiratory infectious diseases. Patients with suspected acute respiratory infectious diseases will be enrolled into this study and received two different diagnostic pathways.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

June 18, 2021

Last Update Submit

May 11, 2022

Conditions

Acute Respiratory InfectionSevere PneumoniaNext Generation SequencingMultiplex PCR

Keywords

mNGSMultiplex PCRAcute Respiratory Infectious DiseaseSevere Pneumonia

Outcome Measures

Primary Outcomes (1)

  • time for targetted antibiotic treatment

    time interval from enrollment to targetted antibiotic treatment initiation

    28 days

Secondary Outcomes (6)

  • Incidence for clinical key events

    28 days

  • Incidence for clinical remission

    28 days

  • Length of hospitalization;

    28 days

  • Length of ICU admission

    28 days

  • Length from admission to clinical events

    28 days

  • +1 more secondary outcomes

Study Arms (2)

mNGS group

EXPERIMENTAL
Diagnostic Test: mNGS

PCR group

EXPERIMENTAL
Diagnostic Test: Multiplex PCR

Interventions

mNGSDIAGNOSTIC_TEST

Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.

mNGS group
Multiplex PCRDIAGNOSTIC_TEST

Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.

PCR group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 80 years old
  • No limits in gender
  • Patients who are newly present with cough, sputum, or exacerbated with pyogenic sputum, with or without chest pain within 2 weeks;
  • Patients who meet at least one of the following 4 requirements:
  • fever;
  • Sign of pulmonary consolidation or wet wales
  • WBC\>10×10\^9/L or \<4×10\^9/L;
  • patchy, infiltrating shadows or interstitial changes, with or without pleural effusion on chest radiological examination.

You may not qualify if:

  • Highly suspected or diagnosed pulmonary non-infectious disease (Tumor, Immune disease, etc.) without evidence for infection;
  • Pathogen has been identified without evidence for co-infection;
  • Insufficiency of respiratory and blood samples;
  • Patients who are unable to collaborate due to physical or mental disorders;
  • Patients who have been engaged to other clinical trials;
  • Any conditions make it unsafe for the subject to participate;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Central Hospital of Jingan District

Shanghai, Shanghai Municipality, 200040, China

NOT YET RECRUITING

Department of Infectious Disease, Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Central Hospital of Minhang District

Shanghai, Shanghai Municipality, 201103, China

NOT YET RECRUITING

Related Publications (1)

  • Yuan G, Wang H, Zhao Y, Mao E, Li M, Wang R, Zhou F, Jin S, Zhang Z, Xu K, Xu J, Liang S, Li X, Jiang L, Zhang L, Song J, Yang T, Guo J, Zhang H, Zhou Y, Wang S, Qiu C, Jiang N, Ai J, Wu J, Zhang W. Early identification and severity prediction of acute respiratory infection (ESAR): a study protocol for a randomized controlled trial. BMC Infect Dis. 2022 Jul 20;22(1):632. doi: 10.1186/s12879-022-07552-7.

    PMID: 35858876DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Wenhong Zhang, Prof

    Department of Infectious disease, Huashan Hospital, Fudan University

    STUDY CHAIR

Central Study Contacts

Hongyu Wang, Dr

CONTACT

17717366509wubywang961208@gmail.com

Jingwen Ai, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chairman of the infectious disease department

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 9, 2021

Study Start

April 4, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)