Ensayos clínicos

Inclusion Criteria:

“VAI  Subject”

 Any PICU patient with an endotracheal or tracheostomy tube on the ventilator greater than 48 hours who has had a respiratory secretion culture obtained and has been treated with antibiotics for > 3 days for suspicion of nosocomial respiratory infection. 

1. Endotracheal or tracheostomy tube and ventilated > 48 hours
2. A respiratory secretion culture (tracheal aspirate, bronchoalveolar lavage, or “mini-BAL”) obtained as part of evaluation for possible infection at any time in the 3 days prior to the study day.
3. Antibiotic treatment for > 3 days (if antibiotic treatment has just been started subject must be followed to determine if treatment extended beyond day 3)
4. Confirmation by the patient’s physician that the antibiotics the patient is receiving are for treatment of a nosocomial respiratory infection. If the subject was on antibiotics prior to obtaining respiratory cultures it must be ascertained that the current antibiotic(s) were initiated or continued for treatment of nosocomial respiratory infection.
5. The infection had to have occurred greater than 48 hours after intubation (that is, it was nosocomial, not pre-existing).

“Evaluation Only”

Any PICU patient with an endotracheal or tracheostomy tube on the ventilator for greater than 48 hours who has had a respiratory secretion culture obtained and has been treated for 3 or fewer days of antibiotics specifically related to that evaluation.      

1. Endotracheal or tracheostomy tube and ventilated > 48 hours.
2. A respiratory secretion culture (tracheal aspirate, bronchoalveolar lavage, or “mini-BAL”) obtained as part of evaluation for possible infection in the 3 days prior to the study day.
3. Antibiotics were either not started or were discontinued ≤ 3 continuous days after the respiratory secretion culture was obtained.  If the subject was on antibiotics prior to obtaining respiratory secretion cultures either no new antibiotics were initiated or newly initiated antibiotics were stopped at ≤ 3 days. (if antibiotic treatment has just been started subject must be followed to determine if treatment extended beyond day 3)

Exclusion Criteria:  

“VAI Subject”

1. On mechanical ventilation < 48 hours when respiratory secretions obtained
2. If blood, urine, or other cultures taken at the time respiratory secretions were cultured are positive or the indication for antibiotics is not clearly for treatment of VAI

“Evaluation Only”

1. On mechanical ventilation < 48 hours when respiratory secretions were obtained