Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

Phase 2

• Conditions: Tracheobronchitis
• Interventions: Drug: Piperacillin/Tazobactam for 7 days

• Registration Number: NCT01027832
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-26
• Status Verified: 2009-12
• Study First Submitted QC: 2009-12-08
• Last Update Submitted: 2009-12-08
• Study First Posted: 2009-12-09
• Last Update Posted: 2009-12-09
• Primary Completion: 2010-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Piperacillin/Tazobactam for 7 days	antibiotics

Primary Outcome Measures

Name	Time	Method
Rate of development of new pneumonia	2 years

Secondary Outcome Measures

Name	Time	Method
ICU length of stay (LOS) and mortality	2 years

Trial Locations

Locations (1)

Assaf Harofe MC; 🇮🇱 Beer Yakov, Zerifin, Israel