Multi-drug Resistant Gram-negative Bacilli Colonization Clinical Trial
Official title:
IGHID 11519 - Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn
| Verified date | October 2018 |
| Source | University of North Carolina, Chapel Hill |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | December 2017 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of North Carolina Jaycee Burn Center | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | North Carolina Translational and Clinical Sciences Institute |
United States,
American Burn Association. National Burn Repository 2014 Report. Available at http://www.ameriburn.org/2014NBRAnnualReport.pdf. Accessed December 23, 2014.
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* Note: There are 17 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Species causing MDR-GNB colonization | 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) | |
| Primary | Time to MDR-GNB colonization | 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) | |
| Primary | Time to development of MDR and extreme drug resistant bacteria | 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) | |
| Primary | Time to VAT/VAP | 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) | |
| Primary | Time to MDR-GNB VAT/VAP | From hospital admission until date of development of MDR-GNB VAT/VAP or date of death from any cause (assessed up to 52 weeks) |