Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn

Completed

• Conditions: Multi-drug Resistant Gram-negative Bacilli Colonization
• Interventions: Other: MDR-GNB

• Registration Number: NCT02653157
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Burn patients with VAT or VAP with MDR-GNB	MDR-GNB	Adult patients with burn and/or inhalation injury requiring intubation

Primary Outcome Measures

Name	Time	Method
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)
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 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 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

Trial Locations

Locations (1)

University of North Carolina Jaycee Burn Center; 🇺🇸 Chapel Hill, North Carolina, United States