Multi-drug Resistant Gram-negative Bacilli Colonization
Conditions
Keywords
multidrug resistance, burns, infections, gram-negative bacilli, ventilator-associated pneumonia, ventilator-associated tracheobronchitis, gram-negative bacilli colonization
Brief summary
This is a prospective observational study to determine the role of colonization and identify the timing of development of drug resistance in multidrug resistant Gram-negative bacilli (MDR-GNB) causing infection among critically ill burn patients.
Detailed description
This is a prospective observational study. Patients will be followed during a single admission for development of colonization or infection with MDR-GNB. Patient clinical characteristics, including infections, surgeries, and antibiotic exposure, will be collected in real-time. Weekly surveillance wound and peri-rectal swabs and, if intubated, biweekly deep endotracheal or tracheostomy aspirates will be collected, de-identified, and stored from all patients and examined for the presence of MDR-GNB. All GNB isolates from blood, urine, respiratory, and wound cultures will be collected, coded, and stored.
Interventions
OTHERMDR-GNB
Sponsors
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Severe burn injury, including partial or full thickness burn 20% or more total body surface area; or 2. inhalation injury; or 3. 18 years of age or older;
Exclusion criteria
1. Intensive care unit stay of less than 5 days; 2. ICU admission more than 48 hours after burn trauma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Species causing MDR-GNB colonization | From hospital admission through length of hospital stay, or date of death from any cause, whichever comes first (assessed up to 52 weeks) | Endotracheal tube or tracheostomy aspirates will be obtained upon admission and twice weekly; wound and perirectal area swabs will be collected weekly and will be used to characterize species. |
| Time to MDR-GNB colonization | From hospital admission until discharge from unit, or date of death from any cause (assessed up to 1 year) | surveillance samples for bacterial colonization will be collected weekly |
| Time to development of MDR and extreme drug resistant bacteria | From hospital admission until date of development of MDR or extremely drug resistant bacteria (assessed up to 52 weeks) | surveillance samples will be collected weekly |
| Time to VAT/VAP | Time of hospital admission until date of development of VAT/VAP or date of death from any cause (assessed up to 52 weeks) | defined by bacteria obtained from clinical bronchoscopy and patient symptoms as noted by chart review |
| Time to MDR-GNB VAT/VAP | From hospital admission until date of development of MDR-GNB VAT/VAP or date of death from any cause (assessed up to 52 weeks) | — |
Countries
United States
Outcome results
None listed