Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)
NCT ID: NCT01027832
Last Updated: 2009-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2009-09-30
2011-09-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control arm
no intervention
No interventions assigned to this group
Experimental arm
antibiotics
Piperacillin/Tazobactam for 7 days
Piperacillin/Tazobactam for 7 days
Interventions
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Piperacillin/Tazobactam for 7 days
Piperacillin/Tazobactam for 7 days
Eligibility Criteria
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Inclusion Criteria
* Purulent sputum with \> 10 x 4 CFU
* Leukocytosis or leukopenia
* Fever
* No pneumonia on CT scan
Exclusion Criteria
* Abnormal Chest X-ray
* Evidence of Pneumonia on CT scan
18 Years
ALL
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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AGeneral ICU, Assaf Harofe MC, Zerifin 70300, Israel
Principal Investigators
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Arie Soroksky, MD
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv University, Faculty of Medicine, Israel.
Locations
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Assaf Harofe MC
Beer Yakov, Zerifin, Israel
Countries
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Central Contacts
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Facility Contacts
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Arie Soroksky, M.D.
Role: primary
Other Identifiers
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102/09
Identifier Type: -
Identifier Source: org_study_id