Ventilator Associated PneumoniaNCT01975350
Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia
An observational study of Ventilator Associated Pneumonia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- Type of treatment
- Injection or infusion
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2013to 31 Aug 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in medical intensive care unit with ventilator use
Who may be able to join
- age ≥ 20 years old
- medical ICU patients with invasive ventilator use ≥ 48 hours
- multidrug resistant Gram-negative bacteria obtained from lower respiratory tract
Who cannot join
- pregnancy
- concurrent use of other antimicrobial agents active for isolated multidrug resistant Gram-negative bacteria (as defined as resistant to carbapenem, fluoroquinolone, and anti-pseudomonas beta-lactams), such as tigecycline, aminoglycosides, and sulbactam
- patients who refuse to receive any inhaled therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria
There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.
Read the detailed description
Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Colistimethate sodium inhalation
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Colistimethate sodium inhalation | Colistimethate sodium inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria. Additional intravenous colistimethate sodium for patients with ventilator-associated pneumonia | |
| saline inhalation | saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical cure rate
including clinical improvement and microbiological outcome(eradication of the pathogen as no growth of the pathogen in the final culture of specimens during the entire hospitalization)
Measured: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
Secondary outcomes (6)
intensive care unit stay
Measured: From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months
hospital stay
Measured: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
all cause mortality
Measured: From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days
ventilator-associated pneumonia-related mortality
Measured: Death that occurred during the colistimethate sodium treatment period when the signs of pneumonia remained and as death due to septic shock, assessed up to 28 days
microbiologic eradication in colonization patients
Measured: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
ventilator-associated pneumonia rate
Measured: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study start1 Oct 2013
- Primary completion4 Feb 2016
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang-Huei Sheng, M.D. Ph.D, Principal investigator, Center of Infection Control of National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975350
- Sponsor's protocol ID
- 201303119MINB
- Status last verified
- Oct 2013
- First submitted
- 22 Oct 2013
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Tracheobronchitis/Pneumonia or Lower Respiratory Tract Colonization by Multidrug Resistant Gram-negative Bacteria
- ClinicalTrials.gov ID
- NCT01975350
- Acronym / sponsor ID
- 201303119MINB
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Colistimethate sodium inhalation
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2013
- Primary completion
- 4 Feb 2016 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 4 Nov 2013 (estimated)
- 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.
There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.
Detailed description
Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colistimethate sodium inhalation | – | –Colistimethate sodium inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria. Additional intravenous colistimethate sodium for patients with ventilator-associated pneumonia |
| saline inhalation | – | –saline inhalation for patients with ventilator-associated tracheobronchitis, pneumonia or lower respiratory tract colonization by multidrug resistant Gram-negative bacteria. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in medical intensive care unit with ventilator use
Key inclusion criteria (3 listed)
- age ≥ 20 years old
- medical ICU patients with invasive ventilator use ≥ 48 hours
- multidrug resistant Gram-negative bacteria obtained from lower respiratory tract
Key exclusion criteria (3 listed)
- pregnancy
- concurrent use of other antimicrobial agents active for isolated multidrug resistant Gram-negative bacteria (as defined as resistant to carbapenem, fluoroquinolone, and anti-pseudomonas beta-lactams), such as tigecycline, aminoglycosides, and sulbactam
- patients who refuse to receive any inhaled therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical cure rate
Time frame: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
including clinical improvement and microbiological outcome(eradication of the pathogen as no growth of the pathogen in the final culture of specimens during the entire hospitalization)
6 secondary outcomes
intensive care unit stay
Time frame: From date of starting colistimethate sodium to discharge date of intensive care unit, assessed up to 3 months
hospital stay
Time frame: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
all cause mortality
Time frame: From date of starting colistimethate sodium to 28th days or til death, whichever came first, assessed up to 28 days
ventilator-associated pneumonia-related mortality
Time frame: Death that occurred during the colistimethate sodium treatment period when the signs of pneumonia remained and as death due to septic shock, assessed up to 28 days
microbiologic eradication in colonization patients
Time frame: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 days
ventilator-associated pneumonia rate
Time frame: From date of starting colistimethate sodium to discharge date of hospital, assessed up to 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
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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.
Wang-Huei Sheng, M.D. Ph.D principal investigator
Center of Infection Control of National University Hospital
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 Ventilator Associated Pneumonia, run by National Taiwan University Hospital 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 Mar 2021. 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?
The study was stopped early. Results are not available in the source record.
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 cure rate (time frame: From date of starting colistimethate sodium to 28th days or til discharge from hospital, whichever came first, assessed up to 28 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 16 Mar 2021.