Inhalation PneumoniaNCT06230614
Effect of Diluent Volume on Colistin Inhalation Therapy
A study testing Colistin 1 MU in normal saline 1 ml and Colistin 1 MU in normal saline 2 ml in people with Inhalation Pneumonia, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the impact of different diluent volumes for the same dosage of colistin in mechanically ventilated respiratory patients receiving colistin inhalation therapy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Inhalation Pneumonia
- What is being tested?
- Colistin 1 MU in normal saline 1 ml and Colistin 1 MU in normal saline 2 ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Mar 2024to 31 Jul 2026
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to the Intensive Care Unit.
- Age greater than 18 years and using a ventilator due to acute respiratory failure.
- Requires inhalation colistin treatment as determined by the disease.
- Sign the written informed consent form.
Who cannot join
- Renal failure requiring renal dialysis.
- Receiving both inhaled colistin and intravenous colistin treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Ke-Yun Chao, PhD, +886-905-301-879, ck_qq@hotmail.com
Ke-Yun Chao, PhD
About this study
Official title: Effect of Diluent Volume on Colistin Inhalation Therapy for Mechanically Ventilated Respiratory Patients
The aim of this study is to investigate the impact of different diluent volumes for the same dosage of colistin in mechanically ventilated respiratory patients receiving colistin inhalation therapy. The study aims to determine whether the diluent volume has an effect on clinical outcomes, including ICU length of stay, total hospitalization duration, duration of respiratory support within 28 days, mortality rates within 28 days and 90 days, as well as analyze the pharmacokinetic profile of colistin in blood and bronchoalveolar lavage fluid. Additionally, the study will evaluate the incidence of nebulizer malfunctions and blockages. The findings of this research will help identify the optimal diluent volume for colistin inhalation therapy in clinical practice.
Read the detailed description
Background： Colistin is an antibiotic used to treat infections caused by multidrug-resistant Gram-negative bacteria. In recent years, it has been widely utilized as an inhaled antibiotic for the treatment of respiratory infections in critically ill patients on mechanical ventilation. Despite the increasing use of colistin inhalation therapy for ventilator-associated pneumonia, the clinical impact of diluent volume on nebulization efficiency remains unclear.
Study Design： A single-center, prospective, randomized controlled trial.
Methods： The study plans to enroll 60 participants. Colistin inhalation therapy will be administered using a blocked stratified random allocation. The control group will receive colistin 6 MU diluted in 6 ml of normal saline (1 MU per 1 ml), while the experimental group will receive colistin 6 MU diluted in 12 ml of normal saline (1 MU per 2 ml). The dosage, frequency, and administration method of colistin inhalation will follow the clinical standard of 6 MU, administered every 8 hours, continuously for 7 days.
Effect： The investigators anticipate that the clinical outcomes and pharmacokinetics of colistin inhalation therapy will not differ significantly between different diluent volumes. Based on comprehensive evaluation, a diluent volume of 12 ml is considered more suitable than 6 ml for the dilution of colistin.
- Conditions
- Inhalation Pneumonia
- Being tested
- Colistin 1 MU in normal saline 1 ml, Colistin 1 MU in normal saline 2 ml
- Keywords
- Colistin, antibiotic, inhalation therapy, diluent volume, randomized controlled trial
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colistin 1 MU in normal saline 1 mlOther
Colistin 1 MU diluted in normal saline 1 ml, total volume of 12 ml
Colistin 1 MU in normal saline 2 mlOther
Colistin 1 MU diluted in normal saline 2 ml, total volume of 12 ml
| Study group | Role | What they receive |
|---|---|---|
| Colistin 1 MU in normal saline 1 ml | Active comparator | 1 MU of colistin in a total volume of 6 ml, diluted with a 1:1 ratio in normal saline (0.9%) Receives: Other: Colistin 1 MU in normal saline 1 ml |
| Colistin 1 MU in normal saline 2 ml | Experimental | 1 MU of colistin in a total volume of 12 ml, diluted with a 1:2 ratio in normal saline (0.9%) Receives: Other: Colistin 1 MU in normal saline 2 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug concentration
Drug concentration in bronchoalveolar lavage fluid and blood
Measured: One hour post inhalation therapy with colistin on the third day of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start10 Mar 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation PneumoniaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230614
- Sponsor's protocol ID
- FJUH112294
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diluent Volume on Colistin Inhalation Therapy for Mechanically Ventilated Respiratory Patients
- ClinicalTrials.gov ID
- NCT06230614
- Acronym / sponsor ID
- FJUH112294
- Conditions
- Inhalation Pneumonia
- Keywords
- Colistin, antibiotic, inhalation therapy, diluent volume, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 30 Jan 2024 (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 aim of this study is to investigate the impact of different diluent volumes for the same dosage of colistin in mechanically ventilated respiratory patients receiving colistin inhalation therapy. The study aims to determine whether the diluent volume has an effect on clinical outcomes, including ICU length of stay, total hospitalization duration, duration of respiratory support within 28 days, mortality rates within 28 days and 90 days, as well as analyze the pharmacokinetic profile of colistin in blood and bronchoalveolar lavage fluid. Additionally, the study will evaluate the incidence of nebulizer malfunctions and blockages. The findings of this research will help identify the optimal diluent volume for colistin inhalation therapy in clinical practice.
Detailed description
Background： Colistin is an antibiotic used to treat infections caused by multidrug-resistant Gram-negative bacteria. In recent years, it has been widely utilized as an inhaled antibiotic for the treatment of respiratory infections in critically ill patients on mechanical ventilation. Despite the increasing use of colistin inhalation therapy for ventilator-associated pneumonia, the clinical impact of diluent volume on nebulization efficiency remains unclear.
Study Design： A single-center, prospective, randomized controlled trial.
Methods： The study plans to enroll 60 participants. Colistin inhalation therapy will be administered using a blocked stratified random allocation. The control group will receive colistin 6 MU diluted in 6 ml of normal saline (1 MU per 1 ml), while the experimental group will receive colistin 6 MU diluted in 12 ml of normal saline (1 MU per 2 ml). The dosage, frequency, and administration method of colistin inhalation will follow the clinical standard of 6 MU, administered every 8 hours, continuously for 7 days.
Effect： The investigators anticipate that the clinical outcomes and pharmacokinetics of colistin inhalation therapy will not differ significantly between different diluent volumes. Based on comprehensive evaluation, a diluent volume of 12 ml is considered more suitable than 6 ml for the dilution of colistin.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colistin 1 MU in normal saline 1 ml | Active comparator | Other: Colistin 1 MU in normal saline 1 ml1 MU of colistin in a total volume of 6 ml, diluted with a 1:1 ratio in normal saline (0.9%) |
| Colistin 1 MU in normal saline 2 ml | Experimental | Other: Colistin 1 MU in normal saline 2 ml1 MU of colistin in a total volume of 12 ml, diluted with a 1:2 ratio in normal saline (0.9%) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to the Intensive Care Unit.
- Age greater than 18 years and using a ventilator due to acute respiratory failure.
- Requires inhalation colistin treatment as determined by the disease.
- Sign the written informed consent form.
Key exclusion criteria (2 listed)
- Renal failure requiring renal dialysis.
- Receiving both inhaled colistin and intravenous colistin treatments.
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 |
|---|---|---|
| Colistin 1 MU in normal saline 1 mlColistin 1 MU diluted in normal saline 1 ml, total volume of 12 ml | Other | Colistin 1 MU in normal saline 1 ml |
| Colistin 1 MU in normal saline 2 mlColistin 1 MU diluted in normal saline 2 ml, total volume of 12 ml | Other | Colistin 1 MU in normal saline 2 ml |
Primary outcome
Drug concentration
Time frame: One hour post inhalation therapy with colistin on the third day of treatment
Drug concentration in bronchoalveolar lavage fluid and blood
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 27 Feb 2026.
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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.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colistin 1 MU in normal saline 1 ml and Colistin 1 MU in normal saline 2 ml in people with Inhalation Pneumonia, run by Fu Jen Catholic University at 1 site in Taiwan.
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 2 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 27 Feb 2026. 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 Taiwan. 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?
Contact Ke-Yun Chao, PhD (+886-905-301-879, C00152@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug concentration (time frame: One hour post inhalation therapy with colistin on the third day of treatment). 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 27 Feb 2026.