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A prospective, open, randomized controlled clinical study of colistimethate sodium aerosol inhalation in the treatment of hospital-acquired pneumonia infected with carbapenem-resistant Acinetobacter baumannii

A prospective, open, randomized controlled clinical study of colistimethate sodium aerosol inhalation in the treatment of hospital-acquired pneumonia infected with carbapenem-resistant Acinetobacter baumannii

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090890
Enrollment
Unknown
Registered
2024-10-15
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

hospital-acquired pneumonia

Interventions

Control group:Nebulized inhalation of 0.9% NaCl solution 3-4 mL + receive standard combination regimen for = 14 days, recommended standard treatment regimens are as follows: Polymyxins + tigecycline/c
Experimental group:Received CMS nebulized inhalation therapy (75 mg/dose, q12h) + standard combination regimen for = 14 days

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Voluntarily participated in this study and signed an informed consent form; (2) Hospitalized patients aged =18 years old, regardless of gender; (3) Clinical and respiratory secretion bacteriologic examination results confirmed CRAB infection; (4) Those who met the diagnostic criteria for HAP (diagnostic criteria refer to the 2018 edition of the Chinese Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia in Adults); (5) Respiratory specimens for culture were obtained within 72 h prior to randomization into groups and after the onset of signs and symptoms of pneumonia (ideally before receiving any antibiotics)

Exclusion criteria

Exclusion criteria: (1) Consider CRAB for colonization; (2) Combination of other sites of infection or multiple pathogens in addition to the lungs; (3) Patients with a history of severe allergy or hypersensitivity to the drugs used in this study; (4) Combined with malignant tumors, hematologic diseases and other serious diseases; (5) Patients with known or suspected active tuberculosis, cystic fibrosis, lung abscess or obstructive pneumonia; (6) Those who have used polymyxin-based nebulized inhalation therapy within 72h prior to enrollment; (7) Participation in other clinical trials within three months; (8) Pregnant or breastfeeding women; (9) Other conditions deemed by the investigator to be unsuitable for enrollment

Design outcomes

Primary

MeasureTime frame
microbial clearance;

Countries

China

Contacts

Public ContactLong Yun

Peking Union Medical Collage Hospital

icu_longyun@126.com+86 139 1160 8699

Outcome results

None listed

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