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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
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Multi-drug Resistant Gram-negative Bacilli Colonization Other: MDR-GNB

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.


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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Group/Cohort Intervention/treatment
Burn patients with VAT or VAP with MDR-GNB
Adult patients with burn and/or inhalation injury requiring intubation
Other: MDR-GNB



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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
Gram-negative bacterial isolates


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
University of North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
Investigators
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Principal Investigator: Anne Lachiewicz, MD, MPH University of North Carolina, Chapel Hill

Additional Information:
Publications:
Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013. Available at http://www.cdc.gov/drugresistance/threat-report-2013 Accessed December 23, 2014.
Siegel JD, Rhinehart E, Jackson M, et al. Management of multidrug-resistant organisms in healthcare settings, 2006. Available at http://www.cdc.gov/hicpac/pdf/MDRO/MDROGuideline2006.pdf. Accessed December 23, 2014.
American Burn Association. National Burn Repository 2014 Report. Available at http://www.ameriburn.org/2014NBRAnnualReport.pdf. Accessed December 23, 2014.

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02653157     History of Changes
Other Study ID Numbers: 15-1505
US NIH Grant KL2TR001109 ( Other Grant/Funding Number: US NIH )
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by University of North Carolina, Chapel Hill:
multidrug resistance
burns
infections, gram-negative bacilli
ventilator-associated pneumonia
ventilator-associated tracheobronchitis
gram-negative bacilli colonization
Additional relevant MeSH terms:
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Infection