Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Not Applicable

Recruiting

• Conditions: Acute Respiratory Infection; Next Generation Sequencing; Severe Pneumonia; Multiplex PCR
• Interventions: Diagnostic Test: mNGS; Diagnostic Test: Multiplex PCR

• Registration Number: NCT04955756
• Lead Sponsor: Huashan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-04
• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1. Patients aged between 18 and 80 years old

2. No limits in gender

3. Patients who are newly present with cough, sputum, or exacerbated with pyogenic sputum, with or without chest pain within 2 weeks;

4. Patients who meet at least one of the following 4 requirements:

   1. fever;
   2. Sign of pulmonary consolidation or wet wales
   3. WBC>10×10^9/L or <4×10^9/L;
   4. patchy, infiltrating shadows or interstitial changes, with or without pleural effusion on chest radiological examination.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mNGS group	mNGS	-
PCR group	Multiplex PCR	-

Primary Outcome Measures

Name	Time	Method
time for targetted antibiotic treatment	28 days	time interval from enrollment to targetted antibiotic treatment initiation

Secondary Outcome Measures

Name	Time	Method
Incidence for clinical key events	28 days	Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Incidence for clinical remission	28 days	Incidence for clinical remission, which achieve the following conditions for over 24 hours: ① heart rate \<100bpm; ② SBP\> 90mmHg; ③Body Temperature \<38℃; ④ SaO2 \> 90% at room temperature;
Length of hospitalization;	28 days	time interval between admission to hispital and discharge from the hospital when a participant is recovered
Length of ICU admission	28 days	time interval from admission to ICU and discharge from ICU
Length from admission to clinical events	28 days	time interval from admission to hospital to clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Sampling to Diagnosis Interval	28 days	time interval from Sampling to Diagnosis

Trial Locations

Locations (3)

Department of Infectious Disease, Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China

Central Hospital of Jingan District; 🇨🇳 Shanghai, Shanghai, China

Central Hospital of Minhang District; 🇨🇳 Shanghai, Shanghai, China