Hospital-acquired Pneumonia (HAP)/ Ventilator-associated Pneumonia (VAP)
Conditions
Interventions
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis meets HAP/VAP diagnostic criteria; 2. The lower respiratory tract specimens (sputum and bronchoalveolar lavage fluid) were cultured with Carbapenem-resistant Organism (CRO); 3. Aged from 18 to 80 years; 4. Women of childbearing age who had a negative urine pregnancy test before administration began and who agreed to use effective contraception throughout the study period; 5. Glomerular filtration rate (eGFR) > 30 mL/min/1.73m^2 (GFR estimated using CKD-EPI formula); 6. Voluntarily (or the legal agent agrees) to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients treated with polymyxin B within 3 days prior to enrollment; 2. Patients with multiple colistin allergic reactions (urticaria, angioedema, allergy, desquamate rash, etc.); 3. Female subjects who are breastfeeding and intend to continue breastfeeding; 4. Patients with a history of epilepsy or myasthenia gravis; 5. Patients without conditions for continuous blood vein collection; 6. Patients who are concomitant or expected to use nephrotoxic drugs (e.g. Vancomycin, Amika magnitude) during the study period; 7. Clinical investigator involved in another investigational drug or investigational device within 3 months prior to the trial; 8. Patients inability or unwillingness to comply with study specific procedures and restrictions; 9. With diseases that the investigator believes may compromise subject safety or affect data quality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polymyxins B concentration and lung penetration in blood and lung lining fluid; | — |
Countries
China
Contacts
Public ContactZhang Jing
Huashan Hospital, Fudan University
Outcome results
None listed