Severe pneumonia (mechanically ventilated patients)
Conditions
Interventions
Experimental treatment group:standard intravenous antibiotics + inhalation of tobramycin solution (300mg/5ml/time, q12h, 7-14 days)
Control group:standard intravenous antibiotics + 0.9% sodium chloride solution (5ml/time, q12h, course of treatment 7-14 days)
Sponsors
The Affiliated Hospital of Medical College Qingdao University, China
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.18 years old <= age < 85 years old; 2. Diagnosis of severe pneumonia (meeting one major criterion and at least three minor criteria); 3. Respiratory failure requiring mechanical ventilation; 4. Pathogenic suspected Gram-negative bacteria infection, including drug-resistant Gram-negative bacteria, should be confirmed by sputum or bronchoalveolar lavage fluid culture or next generation sequencing technology; 5. Written informed consent was obtained from the patient or surrogate.
Exclusion criteria
Exclusion criteria: 1. Allergy to tobramycin or other aminoglycosides; 2. Suspected or pathogen-confirmed pneumonia due to inhalation factors, Gram-positive bacteria, atypical bacteria, viruses or fungi; 3. Inability to tolerate study drug treatment; 4. Have immunosuppression status, such as receiving immunosuppressive therapy, AIDS, etc.; 5. Pregnant or lactating women; 6. Expected survival time < 48 hours; 7. Other patients deemed by the investigator to be ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There was no duration of mechanical ventilation from the initiation of study medication through day 28; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of clinical improvement was studied on day 7 after initiation of drug therapy;Clinical cure rates were studied on day 7 after initiation of drug therapy;The rate of clinical improvement was studied at day 14 after initiation of drug therapy;Clinical cure rates were studied on day 14 after initiation of drug therapy;Clearance of target Gram-negative bacteria from respiratory specimens on day 7 after initiation of drug therapy was studied;Clearance of target Gram-negative bacteria from respiratory specimens on day 14 after initiation of drug therapy was studied;Median duration of antiinfective regimen from initiation of study drug to day 28; | — |
Countries
China
Contacts
Public ContactXing Jinyan
The Affiliated Hospital of Medical College Qingdao University, China
Outcome results
None listed