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Clinical study on the treatment of ventilator-associated pneumonia caused by carbapenem-resistant gram-negative bacilli by intravenous combination of polymyxin E sodium methanesulfonate and nebulized inhalation

Clinical study on the treatment of ventilator-associated pneumonia caused by carbapenem-resistant gram-negative bacilli by intravenous combination of polymyxin E sodium methanesulfonate and nebulized inhalation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072901
Enrollment
Unknown
Registered
2023-06-27
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Ventilator-associated pneumonia

Interventions

Experimental group:Polymyxin E sodium methanesulfonate intravenous combination therapy + Polymyxin E sodium methanesulfonate nebulized inhalation
Control group:Polymyxin E sodium methanesulfonate intravenous combination therapy

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 years and older with a diagnosis of carbapenem-resistant gram-negative bacilli (CR-GNB) caused by patients meeting the diagnostic criteria for ventilator-associated pneumonia (VAP) in the "Guidelines for the diagnosis and treatment of hospital-acquired pneumonia and ventilator-associated pneumonia in adults in China (2018 edition)". Etiology: Gram negative bacilli were isolated from the bronchial secretion after the onset of the disease, and the bacterial culture drug sensitivity results were consistent with Carbapenem resistance.

Exclusion criteria

Exclusion criteria: (1) those with cranio-cerebral disease involving the respiratory center and unable to maintain voluntary respiratory rhythm; (2) those with neuromuscular disease resulting in respiratory muscle weakness; (3) patients with malignancy; (4) patients with end-stage disease; and (5) those with mucin-resistant GNB cultures isolated from respiratory samples in surveillance cultures 7 days prior to inclusion, as well as those using too much mucin E methanesulfonate before enrollment.

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality;—

Secondary

MeasureTime frame
Blood drug concentration, alveolar lavage fluid drug concentration;Calcitoninogen changes, sputum culture microbial clearance;Duration of antibiotic use, duration of mechanical ventilation, duration of ICU stay;Incidence of adverse events after treatment, change in APACHE II score and SOFA score before and after treatment;—

Countries

China

Contacts

Public ContactLi Ma

Second Hospital of Lanzhou University

ery_mali@lzu.edu.cn+86 138 9367 9654

Outcome results

None listed

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