A Study of Ventilator-Associated Infections
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000637
Sponsor Protocol Number: 15-000637
About this study
The purpose of this research is to study the natural history of "ventilator associated pneumonia" and its causes and treatments.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
- Endotracheal or tracheostomy tube and ventilated > 48 hours
- 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.
- Antibiotic treatment for > 3 days (if antibiotic treatment has just been started subject must be followed to determine if treatment extended beyond day 3)
- 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.
- 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.
- Endotracheal or tracheostomy tube and ventilated > 48 hours.
- 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.
- 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”
- On mechanical ventilation < 48 hours when respiratory secretions obtained
- 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”
-
On mechanical ventilation < 48 hours when respiratory secretions were obtained
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Grace Arteaga, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available