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Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01027832
Enrollment
100
Registered
2009-12-09
Start date
2009-09-30
Completion date
2011-09-30
Last updated
2009-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheobronchitis

Keywords

tracheobronchitis

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.

Interventions

DRUGPiperacillin/Tazobactam for 7 days

Piperacillin/Tazobactam for 7 days

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Rate of development of new pneumonia2 years

Secondary

MeasureTime frame
ICU length of stay (LOS) and mortality2 years

Countries

Israel

Contacts

Primary ContactArie Soroksky, MD
soroksky@gmail.com972-8-9779320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026