Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)
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|ClinicalTrials.gov Identifier: NCT01027832|
Recruitment Status : Unknown
Verified December 2009 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : December 9, 2009
Last Update Posted : December 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Tracheobronchitis||Drug: Piperacillin/Tazobactam for 7 days||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT): A Randomized, Controlled Trial|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||September 2011|
No Intervention: Control arm
Experimental: Experimental arm
Drug: Piperacillin/Tazobactam for 7 days
Piperacillin/Tazobactam for 7 days
- Rate of development of new pneumonia [ Time Frame: 2 years ]
- ICU length of stay (LOS) and mortality [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027832
|Contact: Arie Soroksky, MDfirstname.lastname@example.org|
|Assaf Harofe MC||Recruiting|
|Beer Yakov, Zerifin, Israel, 70300|
|Contact: Arie Soroksky, M.D. 972-8-9779320 email@example.com|
|Principal Investigator: Arie Soroksky, M.D.|
|Principal Investigator:||Arie Soroksky, MD||Tel Aviv University, Faculty of Medicine, Israel.|