Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT): A Randomized, Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rate of development of new pneumonia
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Tracheobronchitis as defined by:
- •Purulent sputum with > 10 x 4 CFU
- •Leukocytosis or leukopenia
- •No pneumonia on CT scan
Exclusion Criteria
- •Recent treatment of pneumonia
- •Abnormal Chest X-ray
- •Evidence of Pneumonia on CT scan
Arms & Interventions
Experimental arm
antibiotics
Intervention: Piperacillin/Tazobactam for 7 days (Drug)
Outcomes
Primary Outcomes
Rate of development of new pneumonia
Time Frame: 2 years
Secondary Outcomes
- ICU length of stay (LOS) and mortality(2 years)