TracheobronchitisTRAMANCT01025921
Tracheobronchitis Prevention Trial
A study testing colistin (Tadim) and inhaled normal saline in people with Tracheobronchitis and Pneumonia, run by University of Thessaly at 1 site in Greece.
Trial summary
We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheobronchitis, Pneumonia
- What is being tested?
- colistin (Tadim) and inhaled normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2009to May 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All intubated and tracheostomized patients, older than 18 years old with duration of intubation of 48 hours.
Who cannot join
- Purulent sputum within 48 hours from admission
- Pneumonia within 48 hours of intubation
- New chest X ray infiltrate
- Advanced COPD that led to intubation
- Pregnancy
- Allergy to colistin
- Resistance of the bacterial strain to colistin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Inhaled Antibiotics for Prevention of Tracheobronchitis and Ventilator Associated Pneumonia
We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of tracheal tube and upper airways.
Read the detailed description
INTRODUCTION Gram-negative bacteria have recently become endemic in many ICUs around the world. Ventilator associated pneumonia (VAP) is relatively common and its parenteral treatment often leads to low and sub-therapeutic concentrations of antibiotics in the lung. Ventilator associated tracheobronchitis (VAT) is characterized by fever, purulent sputum, positive cultures of tracheal aspirates secretions and the absence of new pulmonary infiltrates on CXR. This entity is of particular interest because it is an intermediate step in the pathogenesis of VAP (between colonization and VAP itself) and prolongs mechanical ventilatory support. Inhaled antibiotics achieve high (both peak and trough) concentrations in respiratory secretions. Endobronchial antibiotics have been given to non-cystic fibrosis patients for prevention of VAP. Colistimethate sodium (colistin) given by instillation decreased the incidence of Gram-negative pneumonia and did not lead to the development of colistin resistant bacteria.
AIM
The study is a prospective open label randomized study which aims to clarify the effect of colistin to:
- The incidence of VAP The incidence of VAT
- Mechanical ventilation free days
- Incidence of multidrug resistant bacteria in tracheal aspirates cultures
METHODS Settings: The study will be performed in the ICU of the University of Larissa (12 beds).
Entry criteria: All intubated and tracheostomised patients, older than 18 years old with duration of intubation of 48 hours.
Exclusion criteria: 1) Purulent sputum within 48 hours from admission. 2) Pneumonia within 48 hours of intubation 3) New chest X ray infiltrate, 4) Advanced COPD that led to intubation 5) Pregnancy 6) Allergy to colistin 7) Resistance of the bacterial strain to colistin.
Tools: Randomization of the patients into two groups: the first group will receive nebulized colistin and the other no treatment. The initial dose is 1000000 units and it will be doubled after measurement of the drug concentration in tracheal secretions. The drug will start on admission and stop after 10 days.
All patients will be given the respiratory bundle measures (semi-recumbent position, daily interruption of sedation) as part of the usual daily practice of our ICU except otherwise indicated.
The severity of patients will be estimated by APACHE II score on admission and SOFA score thrice weekly. CPIS score as a screening tool for pneumonia will be estimated as well thrice weekly.
Tracheal aspirates cultures on admission and thrice weekly thereafter for the first two weeks and twice weekly thereafter.
The patients will be followed for thirty days to measure outcome.
- Conditions
- Tracheobronchitis, Pneumonia
- Being tested
- colistin (Tadim), inhaled normal saline
- Keywords
- Tracheobronchitis, pneumonia, inhaled antibiotics, colistin, Ventilator associated tracheobronchitis, Ventilator associated pneumonia
- Medical subject headings
- Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colistin (Tadim)Drug
500.000 units of inhaled colistin three times daily for 10 days
inhaled normal salineOther
inhalation of 2,5cc Normal Saline via nebulisation
| Study group | Role | What they receive |
|---|---|---|
| Inhaled colistin | Placebo comparator | They will receive inhaled colistin three times daily for 10 days. Receives: Drug: colistin (Tadim) |
| Inhaled normal saline | Placebo comparator | Inhaled normal saline three times daily for 10 days Receives: Other: inhaled normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of tracheobronchitis and ventilator associated pneumonia
Measured: 30 days
Secondary outcomes (1)
Ventilator free days and ICU length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheobronchitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 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
- NCT01025921
- Sponsor's protocol ID
- MARKAR161109
- Acronym
- TRAMA
- Status last verified
- May 2013
- First submitted
- 3 Dec 2009
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Inhaled Antibiotics for Prevention of Tracheobronchitis and Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT01025921
- Acronym / sponsor ID
- TRAMA / MARKAR161109
- Conditions
- Tracheobronchitis, Pneumonia
- Keywords
- Tracheobronchitis, pneumonia, inhaled antibiotics, colistin, Ventilator associated tracheobronchitis, Ventilator associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Dec 2009 (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.
We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of tracheal tube and upper airways.
Detailed description
INTRODUCTION Gram-negative bacteria have recently become endemic in many ICUs around the world. Ventilator associated pneumonia (VAP) is relatively common and its parenteral treatment often leads to low and sub-therapeutic concentrations of antibiotics in the lung. Ventilator associated tracheobronchitis (VAT) is characterized by fever, purulent sputum, positive cultures of tracheal aspirates secretions and the absence of new pulmonary infiltrates on CXR. This entity is of particular interest because it is an intermediate step in the pathogenesis of VAP (between colonization and VAP itself) and prolongs mechanical ventilatory support. Inhaled antibiotics achieve high (both peak and trough) concentrations in respiratory secretions. Endobronchial antibiotics have been given to non-cystic fibrosis patients for prevention of VAP. Colistimethate sodium (colistin) given by instillation decreased the incidence of Gram-negative pneumonia and did not lead to the development of colistin resistant bacteria.
AIM
The study is a prospective open label randomized study which aims to clarify the effect of colistin to:
- The incidence of VAP The incidence of VAT
- Mechanical ventilation free days
- Incidence of multidrug resistant bacteria in tracheal aspirates cultures
METHODS Settings: The study will be performed in the ICU of the University of Larissa (12 beds).
Entry criteria: All intubated and tracheostomised patients, older than 18 years old with duration of intubation of 48 hours.
Exclusion criteria: 1) Purulent sputum within 48 hours from admission. 2) Pneumonia within 48 hours of intubation 3) New chest X ray infiltrate, 4) Advanced COPD that led to intubation 5) Pregnancy 6) Allergy to colistin 7) Resistance of the bacterial strain to colistin.
Tools: Randomization of the patients into two groups: the first group will receive nebulized colistin and the other no treatment. The initial dose is 1000000 units and it will be doubled after measurement of the drug concentration in tracheal secretions. The drug will start on admission and stop after 10 days.
All patients will be given the respiratory bundle measures (semi-recumbent position, daily interruption of sedation) as part of the usual daily practice of our ICU except otherwise indicated.
The severity of patients will be estimated by APACHE II score on admission and SOFA score thrice weekly. CPIS score as a screening tool for pneumonia will be estimated as well thrice weekly.
Tracheal aspirates cultures on admission and thrice weekly thereafter for the first two weeks and twice weekly thereafter.
The patients will be followed for thirty days to measure outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled colistin | Placebo comparator | Drug: colistin (Tadim)They will receive inhaled colistin three times daily for 10 days. |
| Inhaled normal saline | Placebo comparator | Other: inhaled normal salineInhaled normal saline three times daily for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All intubated and tracheostomized patients, older than 18 years old with duration of intubation of 48 hours.
Key exclusion criteria (7 listed)
- Purulent sputum within 48 hours from admission
- Pneumonia within 48 hours of intubation
- New chest X ray infiltrate
- Advanced COPD that led to intubation
- Pregnancy
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 (Tadim)500.000 units of inhaled colistin three times daily for 10 days | Drug | Inhaled colistin |
| inhaled normal salineinhalation of 2,5cc Normal Saline via nebulisation | Other | Inhaled normal saline |
Primary outcome
Incidence of tracheobronchitis and ventilator associated pneumonia
Time frame: 30 days
1 secondary outcome
Ventilator free days and ICU length of stay
Time frame: 30 days
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 3 Jun 2013.
Related trials for Tracheobronchitis
Active, not recruiting
Ventilator-associated Tracheobronchitis Initiative to Conduct Antibiotic Evaluation
Ventilator Associated Tracheobronchitis, Tracheobronchitis
Not yet recruitingPhase 3
Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis
Ventilator-Associated Pneumonia, Ventilator-Associated Tracheobronchitis
Enrolling by invitationObservational study
A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children
Ventilator Associated Pneumonia, Tracheobronchitis
Not yet recruiting
Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
Nosocomial Infection, Nosocomial 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. This study is not recruiting at the moment.
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 study testing colistin (Tadim) and inhaled normal saline in people with Tracheobronchitis and Pneumonia, run by University of Thessaly at 1 site in Greece.
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 7 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 3 Jun 2013. 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Incidence of tracheobronchitis and ventilator associated pneumonia (time frame: 30 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 3 Jun 2013.