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A Study on the Effects of Different Nebulization Methods of Polymyxin B on the Alveolar Epithelial Lining Fluid Concentration and Clinical Efficacy in Patients with Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria

A Study on the Effects of Different Nebulization Methods of Polymyxin B on the Alveolar Epithelial Lining Fluid Concentration and Clinical Efficacy in Patients with Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111014
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria

Interventions

Experimental group:Vibrating mesh nebulized inhalation of polymyxin B (combined with intravenous drip) 25 mg + 5 mL sterile water for injection, once every 12 hours
Control group:Jet nebulized inhalation of polymyxin B (combined with intravenous drip) 25 mg + 5 mL sterile water for injection, once every 12 hours

Sponsors

Union Hospital, Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for pneumonia specified by the Chinese Medical Association's Society of Respiratory Diseases; 2. CR-GNB is detected in sputum culture and is sensitive to PMB; 3. PMB aerosol inhalation combined with intravenous infusion is used for >=3 days; 4. There is an artificial airway.

Exclusion criteria

Exclusion criteria: 1. Infection with Gram-positive bacteria, viruses, fungi, or infections from other parts of the body other than the lungs; 2. Patients in a dying state; 3. Patients with severe liver and kidney dysfunction; 4. Incomplete clinical data.

Design outcomes

Primary

MeasureTime frame
Overall clinical efficacy rate;

Secondary

MeasureTime frame
Peak and trough concentrations of polymyxin B in epithelial lining fluid (ELF);Bacterial eradication rate;28-day survival rate;Incidence of nephrotoxicity;

Countries

China

Contacts

Public ContactLili Zhou

Union Hospital, Fujian Medical University

Zhoulili@fjmu.edu.cn+86 153 7790 6840

Outcome results

None listed

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