Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn

Study Overview
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Brief Summary
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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
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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.

Official Title
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IGHID 11519 - Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn

Conditions
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Multi-drug Resistant Gram-negative Bacilli Colonization

Intervention / Treatment
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* Other: MDR-GNB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe burn injury, including partial or full thickness burn 20% or more total body surface area; or inhalation injury; or 18 years of age or older; Exclusion Criteria: Intensive care unit stay of less than 5 days; ICU admission more than 48 hours after burn trauma.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Burn patients with VAT or VAP with MDR-GNB<br>Adult patients with burn and/or inhalation injury requiring intubation | Other: MDR-GNB<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Species causing MDR-GNB colonization | 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. | From hospital admission through length of hospital stay, or date of death from any cause, whichever comes first (assessed up to 52 weeks) | 
| Time to MDR-GNB colonization | surveillance samples for bacterial colonization will be collected weekly | From hospital admission until discharge from unit, or date of death from any cause (assessed up to 1 year) | 
| Time to development of MDR and extreme drug resistant bacteria | surveillance samples will be collected weekly | From hospital admission until date of development of MDR or extremely drug resistant bacteria (assessed up to 52 weeks) | 
| Time to VAT/VAP | defined by bacteria obtained from clinical bronchoscopy and patient symptoms as noted by chart review | Time of hospital admission until date of development of VAT/VAP or date of death from any cause (assessed up to 52 weeks) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multidrug resistance, burns, infections, gram-negative bacilli, ventilator-associated pneumonia, ventilator-associated tracheobronchitis, gram-negative bacilli colonization