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NCT Number: NCT02653157

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.

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Key information

Conditions

Multi-drug Resistant Gram-negative Bacilli Colonization Burns Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, 27514, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Severe burn injury, including partial or full thickness burn 20% or more total body surface area; or
  • inhalation injury; or
  • 18 years of age or older;

Exclusion criteria

  • Intensive care unit stay of less than 5 days;
  • ICU admission more than 48 hours after burn trauma.

Treatment and study plan

MDR-GNB

Other

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2016
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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