Content | Screening | Intervention | After intervention | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | Visit 10 | |
Day | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 28 |
Informed consent form | Χ |  |  |  |  |  |  |  |  |  |
Pregnancy test | Χ |  |  |  |  |  |  |  |  |  |
Demographic information | Χ |  |  |  |  |  |  |  |  |  |
Inclusion/exclusion criteria | Χ |  |  |  |  |  |  |  |  |  |
Get SSID and random number | Χ |  |  |  |  |  |  |  |  |  |
History of SP and treatment | Χ |  |  |  |  |  |  |  |  |  |
History of medication and treatment | Χ |  |  |  |  |  |  |  |  |  |
Concomitant diseases | Χ |  |  |  |  |  |  |  |  |  |
Complications | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Body weight and body mass index | Χ |  |  |  |  |  |  |  | Χ |  |
Vital signs | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Laboratory tests | Χ |  |  |  | Χ |  |  |  | Χ |  |
Safety outcomes | Χ |  |  |  | Χ |  |  |  | Χ | Χ |
Mean arterial pressure | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Central venous pressure | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Blood gas analysis | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Mechanical ventilation parameters | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Chest x-ray or CT scan | Χ |  |  |  | Χ |  |  |  | Χ |  |
Sputum and blood culture | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |
Record of routine treatment |  | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |  |
Issue study drug |  | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |  |
Record issue and recovery drug |  | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |  |
Record adverse events |  | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |  |
Severity-of-illness scores | Χ |  |  |  | Χ |  |  |  | Χ |  |
Stage efficacy evaluation |  |  |  |  | Χ |  |  |  | Χ |  |
Length of mechanical ventilation | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Length of stay in ICU | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Length of hospitalization | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Length of antibiotic use | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ | Χ |  |
Efficacy and safety evaluation |  |  |  |  |  |  |  |  | Χ |  |
Main treatment affecting prognosis |  |  |  |  |  |  |  |  |  | Χ |
Survival follow-up |  |  |  |  |  |  |  |  |  | Χ |