Lung Infection BacterialPhase 4NCT06907069
Polycolistin E Sodium Mesylate Combined With Intravenous Atomization for Carbapenem Resistant Gram-negative Bacteria in Pulmonary Infection
A Phase 4 study testing Intravenously atomized polycolistin E sodium mesylate in people with Lung Infection Bacterial, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
Pulmonary infection is a kind of infectious disease that seriously damages human health. It usually starts quickly and progresses rapidly in clinical manifestations, and is often accompanied by upper respiratory tract infection symptoms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Infection Bacterial
- What is being tested?
- Intravenously atomized polycolistin E sodium mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study and sign the informed consent;
- Inpatients aged 18-80 years old, regardless of gender;
- Patients who met the diagnostic criteria for pulmonary infection in the Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia for Adults in China (2018 Edition);
- Infections caused by Gram-negative bacteria (CRO) that are known or strongly suspected to be resistant to carbapenems but sensitive to CMS.
Who cannot join
- Age > 80 years old;
- The patient had a history of severe allergy or hypersensitivity to polymyxins;
- Patients with serious dysfunction of heart, liver, kidney and other important organs;
- Patients with serious diseases such as malignant tumors and blood system diseases;
- Patients with low immune function and risk of opportunistic pathogen infection;
- Patients who used excessive colistin intravenous or atomized inhalation therapy within 72h before enrollment;
Show all 9Show fewer
- Have participated in other clinical trials within three months;
- Pregnant or breastfeeding women;
- There are other circumstances that the researcher believes are not suitable for inclusion.
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
The First Affiliated Hospital of Ningbo University
Ningbo, Z, 315040
About this study
Official title: A Multicenter, Prospective, Open-label Clinical Study on the Treatment of Carbapenem Resistant Gram-negative Bacterial Lung Infection With Sodium Polycolistin E Mesylate Intravenically Combined With Atomization
Pulmonary infection is a kind of infectious disease that seriously damages human health. It usually starts quickly and progresses rapidly in clinical manifestations, and is often accompanied by upper respiratory tract infection symptoms. With the increasing use of broad-spectrum antibiotics in clinical practice, the failure of anti-infection caused by drug-resistant bacteria is more and more common. Once a patient develops carbapenem-resistant gram-negative bacteria (CRO) infection, there are limited drug options. Therefore, HAP, as a serious and common complication, has a high incidence and mortality for ICU patients. In this study, patients who met the diagnostic criteria for pulmonary infection caused by CRO that was clearly or strongly suspected to be resistant to carbapenems but sensitive to CMS were selected, and the combined treatment regimen of CMS intravenous atomization was adopted. To explore the therapeutic effect of CMS combined with intravenous atomization in patients with carbapenem resistant gram-negative bacteria in lung infection. To evaluate the safety and tolerability of the combination regimen in patients with pulmonary infections caused by CRO. The purpose of this study was to explore the efficacy and safety of CMS combined with intravenous atomization in the treatment of patients with CRO induced pulmonary infection, and to provide a basis for its clinical rational application.
- Conditions
- Lung Infection Bacterial
- Being tested
- Intravenously atomized polycolistin E sodium mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenously atomized polycolistin E sodium mesylateDrug
To explore the therapeutic effect of CMS combined with intravenous atomization in patients with carbapenem resistant gram-negative bacteria in lung infection.
| Study group | Role | What they receive |
|---|---|---|
| Intravenously atomized polycolistin E sodium mesylate | Experimental | Not described Receives: Drug: Intravenously atomized polycolistin E sodium mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effective rate
Clinical effective rate = (number of effective cases/total number of treated cases) × 100% Effective cases are those that include complete response (disappearance of symptoms), partial response (significant improvement in symptoms), or those that meet specific efficacy criteria.
Inactive cases are patients whose symptoms do not improve or worsen.
Measured: From enrollment to the end of treatment at 14 days
Secondary outcomes (1)
Microbial clearance
The microbial clearance rate can be calculated by calculating the change in the number of microorganisms before and after disinfection. Specifically, the number of microorganisms before disinfection minus the number of microorganisms after disinfection, divided by the number of microorganisms before disinfection, to obtain the proportion of microbial reduction.
Measured: 14-day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Infection BacterialStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907069
- Sponsor's protocol ID
- 2024-R044-02
- Status last verified
- Mar 2025
- First submitted
- 9 Dec 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open-label Clinical Study on the Treatment of Carbapenem Resistant Gram-negative Bacterial Lung Infection With Sodium Polycolistin E Mesylate Intravenically Combined With Atomization
- ClinicalTrials.gov ID
- NCT06907069
- Acronym / sponsor ID
- 2024-R044-02
- Conditions
- Lung Infection Bacterial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 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.
Pulmonary infection is a kind of infectious disease that seriously damages human health. It usually starts quickly and progresses rapidly in clinical manifestations, and is often accompanied by upper respiratory tract infection symptoms. With the increasing use of broad-spectrum antibiotics in clinical practice, the failure of anti-infection caused by drug-resistant bacteria is more and more common. Once a patient develops carbapenem-resistant gram-negative bacteria (CRO) infection, there are limited drug options. Therefore, HAP, as a serious and common complication, has a high incidence and mortality for ICU patients. In this study, patients who met the diagnostic criteria for pulmonary infection caused by CRO that was clearly or strongly suspected to be resistant to carbapenems but sensitive to CMS were selected, and the combined treatment regimen of CMS intravenous atomization was adopted. To explore the therapeutic effect of CMS combined with intravenous atomization in patients with carbapenem resistant gram-negative bacteria in lung infection. To evaluate the safety and tolerability of the combination regimen in patients with pulmonary infections caused by CRO. The purpose of this study was to explore the efficacy and safety of CMS combined with intravenous atomization in the treatment of patients with CRO induced pulmonary infection, and to provide a basis for its clinical rational application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenously atomized polycolistin E sodium mesylate | Experimental | Drug: Intravenously atomized polycolistin E sodium mesylate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily participate in the study and sign the informed consent;
- Inpatients aged 18-80 years old, regardless of gender;
- Patients who met the diagnostic criteria for pulmonary infection in the Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia for Adults in China (2018 Edition);
- Infections caused by Gram-negative bacteria (CRO) that are known or strongly suspected to be resistant to carbapenems but sensitive to CMS.
Key exclusion criteria (9 listed)
- Age > 80 years old;
- The patient had a history of severe allergy or hypersensitivity to polymyxins;
- Patients with serious dysfunction of heart, liver, kidney and other important organs;
- Patients with serious diseases such as malignant tumors and blood system diseases;
- Patients with low immune function and risk of opportunistic pathogen infection;
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 |
|---|---|---|
| Intravenously atomized polycolistin E sodium mesylateTo explore the therapeutic effect of CMS combined with intravenous atomization in patients with carbapenem resistant gram-negative bacteria in lung infection. | Drug | Intravenously atomized polycolistin E sodium mesylate |
Primary outcome
Clinical effective rate
Time frame: From enrollment to the end of treatment at 14 days
Clinical effective rate = (number of effective cases/total number of treated cases) × 100% Effective cases are those that include complete response (disappearance of symptoms), partial response (significant improvement in symptoms), or those that meet specific efficacy criteria. Inactive cases are patients whose symptoms do not improve or worsen.
1 secondary outcome
Microbial clearance
Time frame: 14-day treatment
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 2 Apr 2025.
Related trials for Lung Infection Bacterial
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenously atomized polycolistin E sodium mesylate in people with Lung Infection Bacterial, run by First Affiliated Hospital of Ningbo University 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 9 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: enrolling by invitation, as of the sponsor's last update on 2 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effective rate (time frame: From enrollment to the end of treatment at 14 days). 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 2 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.