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A prospective clinical observational study on the safety and efficacy of aerosol inhalation of polymyxin B in the treatment of Carbapenem resistant organisms pulmonary infection

A prospective clinical observational study on the safety and efficacy of aerosol inhalation of polymyxin B in the treatment of CRO pulmonary infection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075128
Enrollment
Unknown
Registered
2023-08-25
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

pneumonia

Interventions

atomization group (inhale polymyxin B):NA
Non-atomized group:none

Sponsors

The first affiliated hospital, zhe jiang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The clinician suspects that the lung lesions are infectious or co-infected on the basis of the underlying disease, and there is a positive result of carbapenem-resistant microorganism culture. Specifically include: 1. The diagnosis meets the VAP or HAP criteria and has a positive CRO culture of respiratory secretions; 2. Use a vibrating mesh nebulizer to inhale antibiotics into patients; 3. Clinical use of antibacterial regimens containing polymyxin B nebulization treatment, the treatment course of nebulization inhalation is 3-14 days; 4. Subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents.

Exclusion criteria

Exclusion criteria: 1. Patients who are diagnosed with VAP or HAP for the second time in the same hospitalization period and are treated with antibiotic nebulization; 2. Patients who are aerosolized with antifungal drugs; 3. In the middle of the study, patients or their family members request to stop antibiotic nebulization.

Design outcomes

Primary

MeasureTime frame
Microbial removal;Microorganisms not cleared;30-day mortality;

Secondary

MeasureTime frame
Clinical Outcome Evaluation - Improvement;Clinical Outcome Evaluation - Invalid;Evaluation of clinical outcome - unable to judge;

Countries

China

Contacts

Public ContactHua Zhou

The first affiliated hospital, zhe jiang university

zhouhua1@zju.edu.cn+86 139 5804 8735

Outcome results

None listed

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