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Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

Information source: Assaf-Harofeh Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tracheobronchitis

Intervention: Piperacillin/Tazobactam for 7 days (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Assaf-Harofeh Medical Center

Official(s) and/or principal investigator(s):
Arie Soroksky, MD, Principal Investigator, Affiliation: Tel Aviv University, Faculty of Medicine, Israel.

Overall contact:
Arie Soroksky, MD, Phone: 972-8-9779320, Email: soroksky@gmail.com


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.

Clinical Details

Official title: Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT): A Randomized, Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rate of development of new pneumonia

Secondary outcome: ICU length of stay (LOS) and mortality

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Arie Soroksky, MD, Phone: 972-8-9779320, Email: soroksky@gmail.com

Assaf Harofe MC, Beer Yakov, Zerifin 70300, Israel; Recruiting
Arie Soroksky, M.D., Phone: 972-8-9779320, Email: soroksky@gmail.com
Arie Soroksky, M.D., Principal Investigator
Additional Information

Starting date: September 2009
Last updated: December 8, 2009

Page last updated: August 23, 2015

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