Multidrug-resistant bacterial pneumonia
Conditions
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 130 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Patients who have received invasive mechanical ventilation (via endotracheal intubation or tracheostomy) within 48 hours; 3. Patients judged by the investigator to be expected to require invasive mechanical ventilation for >=48 hours; 4. tNGS testing of lower respiratory tract samples submitted by the investigator shows no detected resistance genes.
Exclusion criteria
Exclusion criteria: 1.Length of stay in a healthcare facility =7 days; 2. Patients judged by the investigator to be expected to die within 48 hours; 3. Detection of drug-resistant bacteria in lower respiratory tract samples within 1 week. Lower respiratory tract samples include endotracheal aspirates, bronchoalveolar lavage (BAL) specimens, deep sputum, blind mini-bronchoalveolar lavage (mini-BAL) specimens, protected specimen brush (PSB) samples, lung tissue biopsy, and pleural effusion. Detection methods include microbiological culture plus antimicrobial susceptibility testing; 4. Detection of drug-resistant bacteria in blood within 1 week; 5. History of Tanreqing Injection use within 1 week; 6. History of inhaled antibacterial drug use within 1 week; 7. Hypersensitivity to Tanreqing Injection or its constituents containing Scutellaria baicalensis, bear bile powder, goat horn, Lonicera japonica (honeysuckle), or Forsythia suspensa, or hypersensitivity to alcohols; 8. History of severe adverse drug reactions; 9. Liver failure (Child-Pugh class C); 10. Chronic renal failure (glomerular filtration rate <15 mL/min, or currently receiving hemodialysis or peritoneal dialysis); 11.End-stage heart failure (progressive structural heart disease with symptoms at rest despite active medical treatment and requiring specialized intervention); 12.Pregnant or lactating women; 13. Participation in any clinical trial within the past 3 months; 14. Refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of multidrug-resistant bacterial pneumonia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of detection of different multidrug-resistant organisms in lower respiratory tract samples submitted by the investigator, as determined by bacterial culture and antimicrobial susceptibility testing;Incidence of detection of different pathogens in lower respiratory tract samples submitted by the investigator, as determined by tNGS;Incidence of different multidrug-resistant organisms detected in all lower respiratory tract samples;Incidence of different multidrug-resistant organisms detected in blood;Incidence of multidrug-resistant bacterial pneumonia;Incidence density of pneumonia caused by multidrug-resistant organisms;Incidence of bacterial pneumonia;Incidence density of bacterial pneumonia;Duration of survival without pneumonia within 7 days;Duration of survival without pneumonia within 14 days;Incidence of bloodstream infection;Level of procalcitonin;Level of C-reactive protein;Level of absolute lymphocyte count;Level of lymphocyte percentage;Days alive and free of antibiotics;Days alive and free of carbapenems;Days alive and free of antibiotics to which the carbapenem-resistant isolate is susceptible;PaO2/FiO2 ratio;Days alive and free of invasive mechanical ventilation;Days alive and free of mechanical ventilation;Days alive and free of vasopressor;Days alive and free of renal replacement therapy;All-cause mortality;Intensive care unit length of stay;Hospital length of stay; | — |
Countries
China
Contacts
Public ContactXin Sun; Kang Yan
West China Hospital, Sichuan University
Outcome results
None listed