CompletedNot Applicable

Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn

United States48 participantsStarted 2015-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Species causing MDR-GNB colonization

Timeframe: 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

Timeframe: 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

Timeframe: From hospital admission until date of development of MDR or extremely drug resistant bacteria (assessed up to 52 weeks)

Time to VAT/VAP

Timeframe: 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

Timeframe: From hospital admission until date of development of MDR-GNB VAT/VAP or date of death from any cause (assessed up to 52 weeks)

Trial details

NCT IDNCT02653157

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-06

View on ClinicalTrials.gov More Multi-drug Resistant Gram-negative Bacilli Colonization trials