Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn
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|ClinicalTrials.gov Identifier: NCT02653157|
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment|
|Multi-drug Resistant Gram-negative Bacilli Colonization||Other: MDR-GNB|
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|
|Actual Enrollment :||48 participants|
|Official Title:||IGHID 11519 - Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||December 2017|
Burn patients with VAT or VAP with MDR-GNB
Adult patients with burn and/or inhalation injury requiring intubation
- Species causing MDR-GNB colonization [ 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) ]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 [ Time Frame: 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 [ Time Frame: 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 Frame: 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 [ 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) ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653157
|United States, North Carolina|
|University of North Carolina Jaycee Burn Center|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Anne Lachiewicz, MD, MPH||University of North Carolina, Chapel Hill|