Clinical trial NCT04955756: Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
Official title: Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Infection
Severe Pneumonia
Next Generation Sequencing
Multiplex PCR
Keywords: mNGS
Multiplex PCR
Acute Respiratory Infectious Disease
Severe Pneumonia
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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;

Primary outcomes:
measure: time for targetted antibiotic treatment
timeFrame: 28 days
Secondary outcomes:
measure: Incidence for clinical key events
timeFrame: 28 days
measure: Incidence for clinical remission
timeFrame: 28 days
measure: Length of hospitalization;
timeFrame: 28 days
measure: Length of ICU admission
timeFrame: 28 days
measure: Length from admission to clinical events
timeFrame: 28 days
measure: Sampling to Diagnosis Interval
timeFrame: 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Central Hospital of Jingan District
state: Shanghai
city: Shanghai
country: China
facility: Department of Infectious Disease, Huashan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital of Minhang District
state: Shanghai
Study officials:
affiliation: Department of Infectious disease, Huashan Hospital, Fudan University
name: Wenhong Zhang, Prof
role: STUDY_CHAIR
References:
citation: 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.