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Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01027832
First received: November 26, 2009
Last updated: December 8, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Tracheobronchitis Drug: Piperacillin/Tazobactam for 7 days Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT): A Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

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

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

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control arm
no intervention
Experimental: Experimental arm
antibiotics
Drug: Piperacillin/Tazobactam for 7 days
Piperacillin/Tazobactam for 7 days

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027832

Contacts
Contact: Arie Soroksky, MD 972-8-9779320 soroksky@gmail.com

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

Responsible Party: Arie Soroksky M.D., AGeneral ICU, Assaf Harofe MC, Zerifin 70300, Israel
ClinicalTrials.gov Identifier: NCT01027832     History of Changes
Other Study ID Numbers: 102/09
Study First Received: November 26, 2009
Last Updated: December 8, 2009

Keywords provided by Assaf-Harofeh Medical Center:
tracheobronchitis

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

ClinicalTrials.gov processed this record on July 25, 2017