Clinical trial NCT02653157: Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn
Official title: IGHID 11519 - Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multi-drug Resistant Gram-negative Bacilli Colonization
Keywords: multidrug resistance
burns
infections, gram-negative bacilli
ventilator-associated pneumonia
ventilator-associated tracheobronchitis
gram-negative bacilli colonization
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2016-01-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (18 years of age or older) hospitalized in the NC Jaycee Burn Center who require intubation at or less than 24 hours prior to admission as well as those with 20% or more total body surface area burn, with the anticipation that these patients will subsequently require intubation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Species causing MDR-GNB colonization
timeFrame: From hospital admission through length of hospital stay, or date of death from any cause, whichever comes first (assessed up to 52 weeks)
measure: Time to MDR-GNB colonization
timeFrame: From hospital admission until discharge from unit, or date of death from any cause (assessed up to 1 year)
measure: Time to development of MDR and extreme drug resistant bacteria
timeFrame: From hospital admission until date of development of MDR or extremely drug resistant bacteria (assessed up to 52 weeks)
measure: Time to VAT/VAP
timeFrame: Time of hospital admission until date of development of VAT/VAP or date of death from any cause (assessed up to 52 weeks)
measure: Time to MDR-GNB VAT/VAP
timeFrame: From hospital admission until date of development of MDR-GNB VAT/VAP or date of death from any cause (assessed up to 52 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Jaycee Burn Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Anne Lachiewicz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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