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Efficacy and Safety Study of Local Amikacin Lavage via Bronchoalveolar Lavage for Treatment of Drug-Resistant Gram-Negative Bacterial Pneumonia

Efficacy and Safety Study of Local Amikacin Lavage via Bronchoalveolar Lavage for Treatment of Drug-Resistant Gram-Negative Bacterial Pneumonia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120200
Enrollment
Unknown
Registered
2026-03-10
Start date
2026-03-10
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Severe pneumonia

Interventions

Control group:Standard anti-infection treatment
Experimental group:Local application of amikacin for pulmonary lavage combined with standard anti-infection treatment

Sponsors

Panyu Maternal And Child Care Service Centre Of Guangzhou
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years, diagnosed with hospital-acquired/ventilator-associated pneumonia; 2. Presence of segmental pneumonia, non-diffuse lung infection; 3. Sputum/BALF culture confirming drug-resistant G- bacteria (Carbapenem-resistant Acinetobacter baumannii/Pseudomonas aeruginosa/Klebsiella pneumoniae, etc.); 4. APACHE II score 10-25, systemic anti-infective treatment >=72 hours ineffective (fever not reduced, oxygenation worsened, infection indicators not decreased).

Exclusion criteria

Exclusion criteria: 1. Patients under 18 years old or over 75 years old; 2. Diffuse pulmonary fibrosis/pulmonary hemorrhage, bronchopleural fistula, severe airway stenosis; 3. History of chronic neurological insufficiency/baseline creatinine clearance <30ml/min; 4. Pregnancy; 5. Allergy to amikacin; 6. At the end stage of disease, with conditions that may affect study participation or outcome assessment, or severe underlying diseases that make it impossible to complete the follow-up required by the study protocol due to end-stage disease.

Design outcomes

Primary

MeasureTime frame
Clinical Cure Rate;Microbiological Eradication Rate;Incidence of Local Adverse Events;Incidence of Nephrotoxicity;

Secondary

MeasureTime frame
28-Day All-Cause Mortality;Length of ICU Stay;Weaning Rate from Mechanical Ventilation;Dynamic Changes of Inflammatory Biomarkers;Incidence of Liver Enzyme Abnormalities;

Countries

China

Contacts

Public ContactYang Kaiying

Panyu Maternal And Child Care Service Centre Of Guangzhou

yukoky_yang@163.com+86 186 6561 2447

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026