Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn

October 11, 2018 updated by: University of North Carolina, Chapel Hill

IGHID 11519 - Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Jaycee Burn Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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
From hospital admission until date of development of MDR or extremely drug resistant bacteria (assessed up to 52 weeks)
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 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)
From hospital admission until date of development of MDR-GNB VAT/VAP or date of death from any cause (assessed up to 52 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

North Carolina Translational and Clinical Sciences Institute

Investigators

  • Principal Investigator: Anne Lachiewicz, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

June 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

January 8, 2016

First Posted (ESTIMATE)

January 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1505
  • US NIH Grant KL2TR001109 (OTHER_GRANT: US NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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