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NCT Number: NCT07086391

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

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.

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Key information

Conditions

Carbapenem-Resistant Enterobacteriaceae Infection Bacterial Infections Bacterial Infections and Mycoses Infections Lung Diseases Pneumonia Pneumonia - Bacterial Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

lili Zhou, MD，MS

CONTACT

[email protected]

15377906840

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pneumonia diagnosed per Chinese Thoracic Society criteria (radiographic + clinical evidence).
  • Sputum culture-confirmed carbapenem-resistant Gram-negative bacteria susceptible to polymyxin B.
  • ≥3 days of aerosolized polymyxin B therapy.
  • Mechanically ventilated with an artificial airway.

Exclusion criteria

  • Polymyxin B aerosol use planned for <3 days.
  • Terminal status (life expectancy <48h).
  • Severe liver/kidney dysfunction (ALT/AST >5× ULN; eGFR <30 mL/min).
  • No informed consent.

Treatment and study plan

Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization

Device
  • 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.

Primary outcomes

  1. Clinical efficacy

    Time frame: Baseline (pre-treatment); End of Treatment (EOT, 14 days after starting polymyxin B)

    Percentage of patients with cure or improvement based on symptom resolution, microbiological clearance, and radiographic findings.

Secondary outcomes

  1. 28-Day Survival Rate

    Time frame: Baseline (pre-treatment); End of Treatment (EOT, 28 days after starting polymyxin B)

    Survival status assessed at 28 days post-treatment initiation.

  2. Microbiological Clearance Rate

    Time frame: Baseline (pre-treatment); End of Treatment (EOT, 14 days after starting polymyxin B)

    Eradication or replacement of carbapenem-resistant pathogens.

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

A Prospective Clinical Study on Different Methods of Aerosolized Polymyxin B Inhalation for the Treatment of Carbapenem-Resistant Gram-Negative Bacterial Pneumonia

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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