Lower respiratory tract infections
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older. 2.APACHE II score between 15 and 25. 3.Confirmed Gram-negative bacterial infection through microbiological testing, with at least one bacterium not resistant to tobramycin. Gram-negative bacteria include: Pseudomonas aeruginosa, Klebsiella pneumoniae, and Escherichia coli. 4.Anticipated use of nebulized tobramycin solution for at least 7 days during hospitalization. 5.Evidence of new acute respiratory symptoms (symptoms onset within less than 14 days): 1)Clinical symptoms (at least one of the following): Newly developed cough or expectoration, chest pain, dyspnea, tachypnea (respiratory rate >20 breaths/minute). 2)Laboratory evidence (at least one of the following): Recorded fever >=38°C, recorded hypothermia 10,000/mm³), decreased white blood cell count (<3,000/mm³). 3)Imaging evidence: Chest X-ray or CT scan showing new or progressive infiltrates. 4)Pulmonary examination abnormalities: Unusual lung sounds found on physical examination. Note: Criteria 1) and 2) must be met, along with either 3) or 4). 6.Willingness to sign an informed consent form and participate in follow-up.
Exclusion criteria
Exclusion criteria: 1.Serum creatinine (SCr) levels exceeding 1.5 times the upper limit of normal. 2.Life-threatening conditions likely to result in imminent death or patients receiving only palliative care measures (oxygenation index =20 mg prednisone or equivalent for > for 14 days, or cumulative dose > 600 mg prednisone. 5.Exclusion of other infections, such as Legionella, viral infections (COVID-19 or seasonal influenza), tuberculosis, nontuberculous mycobacteria (NTM), mucormycosis, Aspergillus, and other specific or mixed infections. 6.Pregnant or lactating women. 7.Cases deemed by the researcher as not meeting the inclusion criteria for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gram-Negative Bacterial Clearance Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Intravenous Antibiotic Use;Gram-Negative Bacterial Clearance Rate;Clinical Improvement Rate;Rate of Adverse Reactions;Change in CPIS Score;Proportion of Multi-Drug Resistant Infections; | — |
Countries
China
Contacts
The First Affiliated Hospital of Kunming Medical University