Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Tracheobronchitis
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Arie Soroksky, MD; Phone Number: 972-8-9779320; Email: soroksky@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; no intervention
Experimental: Experimental arm; antibiotics	Drug: Piperacillin/Tazobactam for 7 days; Piperacillin/Tazobactam for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of development of new pneumonia	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU length of stay (LOS) and mortality	2 years

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Arie Soroksky, MD, Tel Aviv University, Faculty of Medicine, Israel.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: November 26, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 9, 2009
• Last Update Submitted That Met QC Criteria: December 8, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: tracheobronchitis
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Piperacillin; Tazobactam; Piperacillin, Tazobactam Drug Combination
• Other Study ID Numbers: 102/09