Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Assaf-Harofeh Medical Center

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
Tracheobronchitis Drug: Piperacillin/Tazobactam for 7 days 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control arm
no intervention
Experimental: Experimental arm
Drug: Piperacillin/Tazobactam for 7 days
Piperacillin/Tazobactam for 7 days

Primary Outcome Measures :
  1. Rate of development of new pneumonia [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. ICU length of stay (LOS) and mortality [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01027832

Contact: Arie Soroksky, MD 972-8-9779320

Assaf Harofe MC Recruiting
Beer Yakov, Zerifin, Israel, 70300
Contact: Arie Soroksky, M.D.    972-8-9779320   
Principal Investigator: Arie Soroksky, M.D.         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Arie Soroksky, MD Tel Aviv University, Faculty of Medicine, Israel.

Responsible Party: Arie Soroksky M.D., AGeneral ICU, Assaf Harofe MC, Zerifin 70300, Israel Identifier: NCT01027832     History of Changes
Other Study ID Numbers: 102/09
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: December 2009

Keywords provided by Assaf-Harofeh Medical Center:

Additional relevant MeSH terms:
Anti-Bacterial Agents
Piperacillin, tazobactam drug combination
Penicillanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action