Airway ColonizationNCT01802827
Ventilator Associated Tracheobronchitis in the First 14 Days in ICU
An observational study of Airway Colonization and Tracheobronchitis and Pneumonia Associated With Ventilator, run by University of Thessaly.
Trial summary
To investigate the clinical course and risk factors for VAT and the impact of VAT on Intensive Care Unit (ICU) morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Airway Colonization, Tracheobronchitis and Pneumonia Associated With Ventilator
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 2011
- 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: ICU patients ventilated > 48hours
Who may be able to join
- > 48 hours mechanical ventilation
Who cannot join
- immunodeficiency
- pregnancy
- severe COPD, chronic bronchitis, bronchiectasis
- recent pneumonia
About this study
To investigate the clinical course and risk factors for VAT and the impact of VAT on Intensive Care Unit (ICU) morbidity and mortality.
- Keywords
- airway colonization, tracheobronchitis, pneumonia
- Medical subject headings
- Pneumonia
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 |
|---|---|---|
| VAT patients | Patients developing Ventilator Associated Tracheobronchitis | |
| VAP | Patients presenting ventilator associated pneumonia | |
| No ventilator associated infection | patients who do not present ventilator associated infection during their stay in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
we assessed mortality from all causes at 4 weeks
Measured: mortality at 4 weeks
Secondary outcomes (2)
ICU length of stay
Measured: expected average length of stay 15 days
mortality at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startJun 2009
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ColonizationStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efstratios Manoulakas, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802827
- Sponsor's protocol ID
- MARKAR236
- Status last verified
- Feb 2013
- First submitted
- 24 Sep 2012
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator Associated Tracheobronchitis in the First 14 Days in ICU
- ClinicalTrials.gov ID
- NCT01802827
- Acronym / sponsor ID
- MARKAR236
- Keywords
- airway colonization, tracheobronchitis, pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Mar 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.
To investigate the clinical course and risk factors for VAT and the impact of VAT on Intensive Care Unit (ICU) morbidity and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VAT patients | – | –Patients developing Ventilator Associated Tracheobronchitis |
| VAP | – | –Patients presenting ventilator associated pneumonia |
| No ventilator associated infection | – | –patients who do not present ventilator associated infection during their stay in ICU |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients ventilated > 48hours
Key inclusion criteria (1 listed)
- > 48 hours mechanical ventilation
Key exclusion criteria (4 listed)
- immunodeficiency
- pregnancy
- severe COPD, chronic bronchitis, bronchiectasis
- recent pneumonia
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
mortality
Time frame: mortality at 4 weeks
we assessed mortality from all causes at 4 weeks
2 secondary outcomes
ICU length of stay
Time frame: expected average length of stay 15 days
mortality at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Colonization and Tracheobronchitis and Pneumonia Associated With Ventilator, run by University of Thessaly.
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 1 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: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mortality (time frame: mortality at 4 weeks). 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 1 Mar 2013.