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Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

The recruitment status of this study is unknown because the information has not been verified recently.
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
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Rate of development of new pneumonia [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU length of stay (LOS) and mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
Other Name: 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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Israel: Ethics Commission
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
tracheobronchitis

Additional relevant MeSH terms:
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Piperacillin
 Penicillanic Acid
Piperacillin-tazobactam combination product
Tazobactam
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013