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Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.

NCT07086391 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2025-07-25

No results posted yet for this study

Summary

Study Design:

A randomized, open-label, parallel-group clinical trial comparing the efficacy and safety of jet nebulization versus vibrating mesh nebulization of sulfate polymyxin B in mechanically ventilated patients with carbapenem-resistant Gram-negative bacterial pneumonia.

Participants:

144 patients (72 per group) will be enrolled from December 2023 to December 2025.

Interventions:

Group A: 25mg polymyxin B + 5ml sterile water via jet nebulizer (respirator-assisted).

Group B: 25mg polymyxin B + 5ml sterile water via vibrating mesh nebulizer (respirator-assisted).

Both groups receive additional intravenous polymyxin B (2.0mg/kg loading dose, followed by 1.25mg/kg every 12h) starting 12h after nebulization.

Treatment duration: 14 days.

Key Procedures:

Nebulization parameters: Fixed ventilator settings (SIMV+PSV mode, tidal volume 8ml/kg, PEEP 6cmH₂O).

Bronchoalveolar lavage (BAL) and blood sampling:

BAL fluid (BALF) and blood collected pre-nebulization (baseline), 1h post-nebulization, and at steady-state (days 3-7).

BALF analyzed for polymyxin B concentration, urea nitrogen, and inflammatory mediators (IL-6, TNF-α, etc.).

Primary Outcomes:

Clinical efficacy:

Total response rate (cure + improvement). 28-day survival rate. Time to fever resolution and bacterial clearance.

Drug exposure:

Polymyxin B concentration in alveolar epithelial lining fluid (ELF) and blood.

Secondary Outcomes:

Inflammatory response: Changes in BALF and serum IL-6, TNF-α, CRP levels.

Safety:

Nephrotoxicity (changes in serum creatinine/urea nitrogen). Airway complications (bronchospasm incidence).

Assessment Timeline:

Clinical monitoring: Daily evaluation of vital signs, sputum volume, and ventilator parameters.

Lab tests: Blood tests (hematology, renal function, inflammatory markers) at baseline, days 3/7/14.

Microbiological evaluation: Sputum cultures on days 3/7/14.

Statistical Analysis:

Efficacy and safety endpoints compared between groups using t-tests or chi-square tests.

A p-value \<0.05 will be considered statistically significant.

Conditions

  • Carbapenem-Resistant Enterobacteriaceae Infection
  • Pneumonia - Bacterial

Interventions

DEVICE

Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization

* Group A: 25mg polymyxin B sulfate dissolved in 5ml sterile water, administered via jet nebulizer under mechanical ventilation. * Group B: 25mg polymyxin B sulfate dissolved in 5ml sterile water, administered via vibrating mesh nebulizer under mechanical ventilation.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-07-01
Completion
2026-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086391 on ClinicalTrials.gov