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Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

S

Shamir Medical Center (Assaf-Harofeh)

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Tracheobronchitis

Treatments

Drug: Piperacillin/Tazobactam for 7 days

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Control arm
No Intervention group
Description:
no intervention
Experimental arm
Experimental group
Description:
antibiotics
Treatment:
Drug: Piperacillin/Tazobactam for 7 days

Trial contacts and locations

1

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Central trial contact

Arie Soroksky, MD

Data sourced from clinicaltrials.gov

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