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Exploration of tobramycin in lower respiratory tract infections

Exploration of Nebulized Tobramycin in the Treatment of Moderate to Severe Lower Respiratory Tract Infections: A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094433
Enrollment
Unknown
Registered
2024-12-23
Start date
2024-12-23
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower respiratory tract infections

Interventions

Tobramycin:None

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Gram-Negative Bacterial Clearance Rate;

Secondary

MeasureTime 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

Public ContactJianqing Zhang

The First Affiliated Hospital of Kunming Medical University

ydyyzjq@163.com+86 189 8827 2502

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026