Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn

University of North Carolina, Chapel Hill48 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multi-drug Resistant Gram-negative Bacilli Colonization

Interventions

MDR-GNBOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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 frame: 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

Time frame: From hospital admission until date of development of MDR-GNB VAT/VAP or date of death from any cause (assessed up to 52 weeks)

Data from ClinicalTrials.gov

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