Acute Respiratory Infection, Multiplex PCR, Next Generation Sequencing, Severe Pneumonia
Conditions
Keywords
mNGS, Multiplex PCR, Acute Respiratory Infectious Disease, Severe Pneumonia
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.
Interventions
DIAGNOSTIC_TESTmNGS
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
DIAGNOSTIC_TESTMultiplex PCR
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time for targetted antibiotic treatment | 28 days | time interval from enrollment to targetted antibiotic treatment initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence for clinical key events | 28 days | Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT. |
| 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 |
| Length of ICU admission | 28 days | time interval from admission to ICU and discharge from ICU |
Countries
China
Contacts
Primary ContactHongyu Wang, Dr
Backup ContactJingwen Ai, Dr
Outcome results
None listed