Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)
Study Details
Study Description
Brief 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. 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 |
---|---|---|
|
Phase 2/Phase 3 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Control arm no intervention |
|
Experimental: Experimental arm antibiotics |
Drug: Piperacillin/Tazobactam for 7 days
Piperacillin/Tazobactam for 7 days
|
Outcome Measures
Primary Outcome Measures
- Rate of development of new pneumonia [2 years]
Secondary Outcome Measures
- ICU length of stay (LOS) and mortality [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Tracheobronchitis as defined by:
-
Purulent sputum with > 10 x 4 CFU
-
Leukocytosis or leukopenia
-
Fever
-
No pneumonia on CT scan
Exclusion Criteria:
-
Recent treatment of pneumonia
-
Abnormal Chest X-ray
-
Evidence of Pneumonia on CT scan
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Assaf Harofe MC | Beer Yakov | Zerifin | Israel | 70300 |
Sponsors and Collaborators
- Assaf-Harofeh Medical Center
Investigators
- Principal Investigator: Arie Soroksky, MD, Tel Aviv University, Faculty of Medicine, Israel.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 102/09