Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01027832
Collaborator
(none)
100
1
2
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Piperacillin/Tazobactam for 7 days
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT): A Randomized, Controlled Trial
Study Start Date :
Sep 1, 2009
Anticipated Primary Completion Date :
Sep 1, 2010
Anticipated Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control arm

no intervention

Experimental: Experimental arm

antibiotics

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

Outcome Measures

Primary Outcome Measures

  1. Rate of development of new pneumonia [2 years]

Secondary Outcome Measures

  1. ICU length of stay (LOS) and mortality [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Assaf Harofe MC Beer Yakov Zerifin Israel 70300

Sponsors and Collaborators

  • Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Arie Soroksky, MD, Tel Aviv University, Faculty of Medicine, Israel.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01027832
Other Study ID Numbers:
  • 102/09
First Posted:
Dec 9, 2009
Last Update Posted:
Dec 9, 2009
Last Verified:
Dec 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2009