Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

Tracheobronchitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01027832
• Other study ID #: 102/09
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 26, 2009
• Last updated: December 8, 2009
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: December 2009
• Source: Assaf-Harofeh Medical Center
• Contact: Arie Soroksky, MD
• Phone: 972-8-9779320
• Email: soroksky[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tracheobronchitis

Intervention

Drug:
• Piperacillin/Tazobactam for 7 days
Piperacillin/Tazobactam for 7 days

Locations

Country	Name	City	State
Israel	Assaf Harofe MC	Beer Yakov	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of development of new pneumonia		2 years	No
Secondary	ICU length of stay (LOS) and mortality		2 years	No