Polymyxin BNCT06076603
Comparison of Epithelial Lining Fluid and Blood Pharmacokinetics and Pharmacodynamics of Intravenous and Intravenous Plus Nebulized Polymyxin B in Multidrug Resistant Bacteria Ventilator-associated Pneumonia Patients
An observational study of Polymyxin B and Ventilator-associated Pneumonia, run by Southeast University, China at 1 site in China.
Trial summary
The goal of this observational study is to investigate whether intravenous polymyxin B combined with nebulisation achieves better antimicrobial efficacy and clinical outcomes than intravenous use alone in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Polymyxin B, Ventilator-associated Pneumonia, Multidrug Resistant Bacterial Infection
- What is being tested?
- nebulized polymyxin B
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Screening of patients with multiple drug-resistant bacterial infections and ventilator-associated pneumonia admitted to the Intensive Care Department of Affiliated Zhongda Hospital of Southeast University. Based on the medical decisions of clinical physicians, they received intravenous administration of polymyxin B alone and intravenous combination nebulization of polymyxin B. Patients were divided into two groups according to the actual treatment methods of polymyxin B.
Who may be able to join
- 18-80 years old;
- ICU patients;
- Patients with MDR-infected VAP were diagnosed by etiological culture results;
- Expect to receive at least 6 doses (3 days) of polymyxin B;
- Obtain informed consent;
Who cannot join
- The patient has a history of severe hypersensitivity to polymyxin B;
- Patients cannot tolerate alveolar lavage;
- Oncology patients,includes hematologic malignancies;
- Pregnant or lactating women;
- Patients with other conditions that the investigators consider unsuitable for enrollment;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, 210009
Jianfeng Xie, MD, +86-025-83262552, xie820405@126.com
Yingzi Huang, +86-025-83262552, yz_huang@126.com
About this study
The goal of this observational study is to investigate whether intravenous polymyxin B combined with nebulisation achieves better antimicrobial efficacy and clinical outcomes than intravenous use alone in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia. The main questions it aims to answer are:
- When using intravenous polymyxin B to treat patients with ventilator-associated pneumonia caused by multidrug-resistant bacteria in clinical practice, is it necessary to assist with polymyxin B nebulization therapy？
- If necessary, how much dose of nebulization is better? Participants will be divided into two groups based on whether they have received nebulization treatment with polymyxin B in clinical practice. Blood and alveolar lavage fluid samples will be collected after the first dose injection and reaching the steady-state dose, and the drug concentration differences in blood and ELF will be measured in patients who have received intravenous injection of polymyxin B alone and those who have received adjuvant nebulization of polymyxin B, as well as differences in clinical outcomes and side effects.
Researchers will compare the differences in blood and ELF drug concentrations, clinical outcomes, and incidence of side effects between two groups of patients, to see if is it necessary to assist with polymyxin B nebulization therapy in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia.
- Conditions
- Polymyxin B, Ventilator-associated Pneumonia, Multidrug Resistant Bacterial Infection, Pharmacogenomic Drug Interaction
- Being tested
- nebulized polymyxin B
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized polymyxin BDrug
The experimental group received intravenous combined nebulization of polymyxin B
| Study group | Role | What they receive |
|---|---|---|
| Intravenous combined with nebulized polymyxin B | The intravenous combined nebulization patient group was divided into two subgroups based on the different doses received -25mg q12h and 50mg q12h. Patients in the intravenous combination nebulized polymyxin B group received a total medication dose of 1.25 to 1.5mg/kg, of which 25-50mg was used for nebulization and the remaining portion was used for intravenous administration. The specific method of nebulization is to receive nebulized bronchodilator 30 minutes before nebulization, add 25-50mg of polymyxin B to 5ml of physiological saline for dilution, use a vibrating mesh nebulizer to connect to the patient's ventilator pipeline suction tube, do not change the original ventilator parameter settings, and continue nebulization for 30 minutes. After 30 minutes, regardless of whether there is any residue of the nebulized drug, it will be discarded according to general nursing methods. Receives: Drug: nebulized polymyxin B | |
| Intravenous polymyxin group B | This group of patients received intravenous injection of polymyxin B alone, with intravenous doses of 1.25-1.5mg/kg of polymyxin B administered every 12 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration
Blood concentration
Measured: 3 days after the end of the patient's first medication use
ELF concentration
Drug concentration in ELF solution
Measured: 3 days after the end of the patient's first medication use
Secondary outcomes (3)
28-day clinical cure rate
the proportion of subjects who are thought as clinical effectiveness 28 days after treatment with polymyxin B to the number of subjects in each group.
Measured: 28 days after the end of the patient's medication
28-day microbiological cure rate
the proportion of subjects of microbiological cure to the number of subjects in each group 28 days after treatment with polymyxin B.
Measured: 28 days after the end of the patient's medication
28-day adverse reaction rate
the proportion of subjects who experienced adverse reactions within 28 days after treatment with polymyxin B to the number of subjects in each group
Measured: 28 days after the end of the patient's medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyxin BStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Yingzi Huang, MD, Study chair, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076603
- Sponsor's protocol ID
- PMBPIN
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 11 Oct 2023
- 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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epithelial Lining Fluid and Blood Pharmacokinetics and Pharmacodynamics of Intravenous and Intravenous Plus Nebulized Polymyxin B in Multidrug Resistant Bacteria Ventilator-associated Pneumonia Patients
- ClinicalTrials.gov ID
- NCT06076603
- Acronym / sponsor ID
- PMBPIN
- Conditions
- Polymyxin B, Ventilator-associated Pneumonia, Multidrug Resistant Bacterial Infection, Pharmacogenomic Drug Interaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 11 Oct 2023 (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.
The goal of this observational study is to investigate whether intravenous polymyxin B combined with nebulisation achieves better antimicrobial efficacy and clinical outcomes than intravenous use alone in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia. The main questions it aims to answer are:
- When using intravenous polymyxin B to treat patients with ventilator-associated pneumonia caused by multidrug-resistant bacteria in clinical practice, is it necessary to assist with polymyxin B nebulization therapy？
- If necessary, how much dose of nebulization is better? Participants will be divided into two groups based on whether they have received nebulization treatment with polymyxin B in clinical practice. Blood and alveolar lavage fluid samples will be collected after the first dose injection and reaching the steady-state dose, and the drug concentration differences in blood and ELF will be measured in patients who have received intravenous injection of polymyxin B alone and those who have received adjuvant nebulization of polymyxin B, as well as differences in clinical outcomes and side effects.
Researchers will compare the differences in blood and ELF drug concentrations, clinical outcomes, and incidence of side effects between two groups of patients, to see if is it necessary to assist with polymyxin B nebulization therapy in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous combined with nebulized polymyxin B | – | Drug: nebulized polymyxin BThe intravenous combined nebulization patient group was divided into two subgroups based on the different doses received -25mg q12h and 50mg q12h. Patients in the intravenous combination nebulized polymyxin B group received a total medication dose of 1.25 to 1.5mg/kg, of which 25-50mg was used for nebulization and the remaining portion was used for intravenous administration. The specific method of nebulization is to receive nebulized bronchodilator 30 minutes before nebulization, add 25-50mg of polymyxin B to 5ml of physiological saline for dilution, use a vibrating mesh nebulizer to connect to the patient's ventilator pipeline suction tube, do not change the original ventilator parameter settings, and continue nebulization for 30 minutes. After 30 minutes, regardless of whether there is any residue of the nebulized drug, it will be discarded according to general nursing methods. |
| Intravenous polymyxin group B | – | –This group of patients received intravenous injection of polymyxin B alone, with intravenous doses of 1.25-1.5mg/kg of polymyxin B administered every 12 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Screening of patients with multiple drug-resistant bacterial infections and ventilator-associated pneumonia admitted to the Intensive Care Department of Affiliated Zhongda Hospital of Southeast University. Based on the medical decisions of clinical physicians, they received intravenous administration of polymyxin B alone and intravenous combination nebulization of polymyxin B. Patients were divided into two groups according to the actual treatment methods of polymyxin B.
Key inclusion criteria (5 listed)
- 18-80 years old;
- ICU patients;
- Patients with MDR-infected VAP were diagnosed by etiological culture results;
- Expect to receive at least 6 doses (3 days) of polymyxin B;
- Obtain informed consent;
Key exclusion criteria (5 listed)
- The patient has a history of severe hypersensitivity to polymyxin B;
- Patients cannot tolerate alveolar lavage;
- Oncology patients,includes hematologic malignancies;
- Pregnant or lactating women;
- Patients with other conditions that the investigators consider unsuitable for enrollment;
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 |
|---|---|---|
| nebulized polymyxin BThe experimental group received intravenous combined nebulization of polymyxin B | Drug | Intravenous combined with nebulized polymyxin B |
Primary outcome
Blood concentration
Time frame: 3 days after the end of the patient's first medication use
Blood concentration
ELF concentration
Time frame: 3 days after the end of the patient's first medication use
Drug concentration in ELF solution
3 secondary outcomes
28-day clinical cure rate
Time frame: 28 days after the end of the patient's medication
28-day microbiological cure rate
Time frame: 28 days after the end of the patient's medication
28-day adverse reaction rate
Time frame: 28 days after the end of the patient's medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- 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. This study is not recruiting at the moment.
Yingzi Huang, MD study chair
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
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 Polymyxin B and Ventilator-associated Pneumonia, run by Southeast University, China 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingzi Huang, MD (+86-025-83262552, yz_huang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood concentration (time frame: 3 days after the end of the patient's first medication use). The study lists 2 primary outcomes in all. 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 11 Oct 2023.