TracheobronchitisPhase 2/3NCT01027832
Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)
A Phase 2/3 study testing Piperacillin/Tazobactam for 7 days in people with Tracheobronchitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever, and purulent sputum, but without radiological evidence of pneumonia. These patients may have tracheobronchitis. Some suspect that this condition precedes the development of pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheobronchitis
- What is being tested?
- Piperacillin/Tazobactam for 7 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Sep 2011
- Phase
- Phase 2/3
- 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
- Tracheobronchitis as defined by:
- Purulent sputum with > 10 x 4 CFU
- Leukocytosis or leukopenia
- Fever
- No pneumonia on CT scan
Who cannot join
- Recent treatment of pneumonia
- Abnormal Chest X-ray
- Evidence of Pneumonia on CT scan
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofe MC
Beer Yakov, Zerifin, 70300
Arie Soroksky, M.D., 972-8-9779320, soroksky@gmail.com
Arie Soroksky, M.D.
About this study
Official title: Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT): A Randomized, Controlled Trial
Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever, and purulent sputum, but without radiological evidence of pneumonia.
These patients may have tracheobronchitis. Some suspect that this condition precedes the development of pneumonia. Antibiotic treatment in tracheobronchitis is controversial.
The investigators will recruit patients with tracheobronchitis and randomize them into 2 groups. One group will be treated with antibiotics and the other group will serve as control.
Read the detailed description
Patients with proved tracheobronchitis who are mechanically ventilated for more than 48 hrs, will undergo a CT scan to rool our pneumonia that may not be seen on a routine chest x-ray.
After ruling out pneumonia by CT scan, patients will be randomized into 2 groups. Intervention group will receive 7 days of treatment with Piperacillin/Tazobactam. A control group will receive nothing.
Primary endpoint wil be the rate of new pneumonias and secondary endpoint will be ICU Length of stay, days on mechanical ventilation and 28 day mortality.
- Conditions
- Tracheobronchitis
- Being tested
- Piperacillin/Tazobactam for 7 days
- Keywords
- tracheobronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/Tazobactam for 7 daysDrug
Piperacillin/Tazobactam for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | no intervention |
| Experimental arm | Experimental | antibiotics Receives: Drug: Piperacillin/Tazobactam for 7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of development of new pneumonia
Measured: 2 years
Secondary outcomes (1)
ICU length of stay (LOS) and mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2010 (estimated)
- Study completionSep 2011 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Arie Soroksky, MD, Principal investigator, Tel Aviv University, Faculty of Medicine, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027832
- Sponsor's protocol ID
- 102/09
- Status last verified
- Dec 2009
- First submitted
- 26 Nov 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT): A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01027832
- Acronym / sponsor ID
- 102/09
- Conditions
- Tracheobronchitis
- Keywords
- tracheobronchitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 9 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.
Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever, and purulent sputum, but without radiological evidence of pneumonia.
These patients may have tracheobronchitis. Some suspect that this condition precedes the development of pneumonia. Antibiotic treatment in tracheobronchitis is controversial.
The investigators will recruit patients with tracheobronchitis and randomize them into 2 groups. One group will be treated with antibiotics and the other group will serve as control.
Detailed description
Patients with proved tracheobronchitis who are mechanically ventilated for more than 48 hrs, will undergo a CT scan to rool our pneumonia that may not be seen on a routine chest x-ray.
After ruling out pneumonia by CT scan, patients will be randomized into 2 groups. Intervention group will receive 7 days of treatment with Piperacillin/Tazobactam. A control group will receive nothing.
Primary endpoint wil be the rate of new pneumonias and secondary endpoint will be ICU Length of stay, days on mechanical ventilation and 28 day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –no intervention |
| Experimental arm | Experimental | Drug: Piperacillin/Tazobactam for 7 daysantibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Tracheobronchitis as defined by:
Key exclusion criteria (3 listed)
- Recent treatment of pneumonia
- Abnormal Chest X-ray
- Evidence of Pneumonia on CT scan
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 |
|---|---|---|
| Piperacillin/Tazobactam for 7 daysPiperacillin/Tazobactam for 7 days | Drug | Experimental arm |
Primary outcome
Rate of development of new pneumonia
Time frame: 2 years
1 secondary outcome
ICU length of stay (LOS) and mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
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.
Arie Soroksky, MD principal investigator
Tel Aviv University, Faculty of Medicine, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Piperacillin/Tazobactam for 7 days in people with Tracheobronchitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 9 Dec 2009. 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 Israel. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Arie Soroksky, MD (972-8-9779320, soroksky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of development of new pneumonia (time frame: 2 years). 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 9 Dec 2009.