Carbapenem-Resistant Enterobacteriaceae InfectionNCT07086391
Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.
An observational study of Carbapenem-Resistant Enterobacteriaceae Infection and Pneumonia - Bacterial, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carbapenem-Resistant Enterobacteriaceae Infection, Pneumonia - Bacterial
- What is being tested?
- Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Feb 2026
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated adults with carbapenem-resistant Gram-negative bacterial pneumonia (e.g., Pseudomonas aeruginosa) confirmed by sputum culture and susceptible to polymyxin B. Participants must receive ≥3 days of aerosolized polymyxin B via endotracheal tube/tracheostomy. Exclusions: life expectancy <48h, severe liver/kidney dysfunction, or lack of informed consent.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
lili Zhou, MD，MS, 15377906840, zhoulili@fjmu.edu.cn
About this study
Official title: A Prospective Clinical Study on Different Methods of Aerosolized Polymyxin B Inhalation for the Treatment of 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.
Read more
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.
- Being tested
- Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh NebulizationDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: 25mg polymyxin B + 5ml sterile water via jet nebulizer (respirator-assisted). | Not described Receives: Device: Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization | |
| Group B: 25mg polymyxin B + 5ml sterile water via vibrating mesh nebulizer (respirator-assisted). | Not described Receives: Device: Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Percentage of patients with cure or improvement based on symptom resolution, microbiological clearance, and radiographic findings.
Measured: Baseline (pre-treatment); End of Treatment (EOT, 14 days after starting polymyxin B)
Secondary outcomes (2)
28-Day Survival Rate
Survival status assessed at 28 days post-treatment initiation.
Measured: Baseline (pre-treatment); End of Treatment (EOT, 28 days after starting polymyxin B)
Microbiological Clearance Rate
Eradication or replacement of carbapenem-resistant pathogens.
Measured: Baseline (pre-treatment); End of Treatment (EOT, 14 days after starting polymyxin B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Feb 2023
- Primary completion1 Jul 2025
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbapenem-Resistant Enterobacteriaceae InfectionStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Zhou, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086391
- Sponsor's protocol ID
- 2022YF033-03
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study on Different Methods of Aerosolized Polymyxin B Inhalation for the Treatment of Carbapenem-Resistant Gram-Negative Bacterial Pneumonia
- ClinicalTrials.gov ID
- NCT07086391
- Acronym / sponsor ID
- 2022YF033-03
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 25mg polymyxin B + 5ml sterile water via jet nebulizer (respirator-assisted). | – | Device: Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization |
| Group B: 25mg polymyxin B + 5ml sterile water via vibrating mesh nebulizer (respirator-assisted). | – | Device: Polymyxin B Sulfate 25mg Jet Nebulization / Vibrating Mesh Nebulization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated adults with carbapenem-resistant Gram-negative bacterial pneumonia (e.g., Pseudomonas aeruginosa) confirmed by sputum culture and susceptible to polymyxin B. Participants must receive ≥3 days of aerosolized polymyxin B via endotracheal tube/tracheostomy. Exclusions: life expectancy <48h, severe liver/kidney dysfunction, or lack of informed consent.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | 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). |
Primary outcome
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.
2 secondary outcomes
28-Day Survival Rate
Time frame: Baseline (pre-treatment); End of Treatment (EOT, 28 days after starting polymyxin B)
Microbiological Clearance Rate
Time frame: Baseline (pre-treatment); End of Treatment (EOT, 14 days after starting polymyxin B)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbapenem-Resistant Enterobacteriaceae Infection and Pneumonia - Bacterial, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy (time frame: Baseline (pre-treatment); End of Treatment (EOT, 14 days after starting polymyxin B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.