Multi-drug Resistant Gram-negative Bacilli ColonizationNCT02653157
Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn
An observational study of Multi-drug Resistant Gram-negative Bacilli Colonization, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multi-drug Resistant Gram-negative Bacilli Colonization
- What is being tested?
- MDR-GNB
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- Intensive care unit stay of less than 5 days;
- ICU admission more than 48 hours after burn trauma.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, 27514
About this study
Official title: 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.
Read the 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.
- Being tested
- MDR-GNB
- Keywords
- multidrug resistance, burns, infections, gram-negative bacilli, ventilator-associated pneumonia, ventilator-associated tracheobronchitis, gram-negative bacilli colonization
- Medical subject headings
- Burns, Infections, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDR-GNBOther
| Study group | Role | What they receive |
|---|---|---|
| Burn patients with VAT or VAP with MDR-GNB | Adult patients with burn and/or inhalation injury requiring intubation Receives: Other: MDR-GNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
surveillance samples for bacterial colonization will be collected weekly
Measured: 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
surveillance samples will be collected weekly
Measured: From hospital admission until date of development of MDR or extremely drug resistant bacteria (assessed up to 52 weeks)
Time to VAT/VAP
defined by bacteria obtained from clinical bronchoscopy and patient symptoms as noted by chart review
Measured: 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
Measured: From hospital admission until date of development of MDR-GNB VAT/VAP or date of death from any cause (assessed up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Multi-drug Resistant Gram-negative Bacilli ColonizationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Anne Lachiewicz, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653157
- Sponsor's protocol ID
- 15-1505
- Other IDs
- US NIH Grant KL2TR001109
- Status last verified
- Oct 2018
- First submitted
- 19 Oct 2015
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
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.
Mosier MJ, Pham TN. American Burn Association Practice guidelines for prevention, diagnosis, and treatment of ventilator-associated pneumonia (VAP) in burn patients. J Burn Care Res. 2009 Nov-Dec;30(6):910-28. doi: 10.1097/BCR.0b013e3181bfb68f.
PubMed 19826271Brusselaers N, Logie D, Vogelaers D, Monstrey S, Blot S. Burns, inhalation injury and ventilator-associated pneumonia: value of routine surveillance cultures. Burns. 2012 May;38(3):364-70. doi: 10.1016/j.burns.2011.09.005. Epub 2011 Oct 29.
PubMed 22040929Rue LW 3rd, Cioffi WG, Mason AD Jr, McManus WF, Pruitt BA Jr. The risk of pneumonia in thermally injured patients requiring ventilatory support. J Burn Care Rehabil. 1995 May-Jun;16(3 Pt 1):262-8. doi: 10.1097/00004630-199505000-00008.
PubMed 7673306Shirani KZ, Pruitt BA Jr, Mason AD Jr. The influence of inhalation injury and pneumonia on burn mortality. Ann Surg. 1987 Jan;205(1):82-7. doi: 10.1097/00000658-198701000-00015.
PubMed 3800465Tedja R, Nowacki A, Fraser T, Fatica C, Griffiths L, Gordon S, Isada C, van Duin D. The impact of multidrug resistance on outcomes in ventilator-associated pneumonia. Am J Infect Control. 2014 May;42(5):542-5. doi: 10.1016/j.ajic.2013.12.009. Epub 2014 Mar 14.
PubMed 24630700Lachiewicz AM, van Duin D, DiBiase LM, Jones SW, Carson S, Rutala WA, Cairns BA, Weber DJ. Rates of hospital-associated respiratory infections and associated pathogens in a regional burn center, 2008-2012. Infect Control Hosp Epidemiol. 2015 May;36(5):601-3. doi: 10.1017/ice.2014.90. Epub 2015 Jan 28. No abstract available.
PubMed 25626446Craven DE, Hjalmarson KI. Ventilator-associated tracheobronchitis and pneumonia: thinking outside the box. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S59-66. doi: 10.1086/653051.
PubMed 20597674Sievert DM, Ricks P, Edwards JR, Schneider A, Patel J, Srinivasan A, Kallen A, Limbago B, Fridkin S; National Healthcare Safety Network (NHSN) Team and Participating NHSN Facilities. Antimicrobial-resistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2009-2010. Infect Control Hosp Epidemiol. 2013 Jan;34(1):1-14. doi: 10.1086/668770. Epub 2012 Nov 27.
PubMed 23221186Siegel 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.
de La Cal MA, Cerda E, Garcia-Hierro P, Lorente L, Sanchez-Concheiro M, Diaz C, van Saene HK. Pneumonia in patients with severe burns : a classification according to the concept of the carrier state. Chest. 2001 Apr;119(4):1160-5. doi: 10.1378/chest.119.4.1160.
PubMed 11296184American Burn Association. National Burn Repository 2014 Report. Available at http://www.ameriburn.org/2014NBRAnnualReport.pdf. Accessed December 23, 2014.
Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28.
PubMed 23188467Weber DJ, van Duin D, DiBiase LM, Hultman CS, Jones SW, Lachiewicz AM, Sickbert-Bennett EE, Brooks RH, Cairns BA, Rutala WA. Healthcare-associated infections among patients in a large burn intensive care unit: incidence and pathogens, 2008-2012. Infect Control Hosp Epidemiol. 2014 Oct;35(10):1304-6. doi: 10.1086/678067. Epub 2014 Sep 2. No abstract available.
PubMed 25203188Wibbenmeyer L, Danks R, Faucher L, Amelon M, Latenser B, Kealey GP, Herwaldt LA. Prospective analysis of nosocomial infection rates, antibiotic use, and patterns of resistance in a burn population. J Burn Care Res. 2006 Mar-Apr;27(2):152-60. doi: 10.1097/01.BCR.0000203359.32756.F7.
PubMed 16566558
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGHID 11519 - Multidrug Resistant Gram-negative Bacilli Colonization and Infection in Burn
- ClinicalTrials.gov ID
- NCT02653157
- Acronym / sponsor ID
- 15-1505
- Keywords
- multidrug resistance, burns, infections, gram-negative bacilli, ventilator-associated pneumonia, ventilator-associated tracheobronchitis, gram-negative bacilli colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- Oct 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn patients with VAT or VAP with MDR-GNB | – | Other: MDR-GNBAdult patients with burn and/or inhalation injury requiring intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (2 listed)
- Intensive care unit stay of less than 5 days;
- ICU admission more than 48 hours after burn trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDR-GNB | Other | Burn patients with VAT or VAP with MDR-GNB |
Primary outcome
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.
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
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
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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- BackgroundCenters 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.
- Background: PubMed 19826271Mosier MJ, Pham TN. American Burn Association Practice guidelines for prevention, diagnosis, and treatment of ventilator-associated pneumonia (VAP) in burn patients. J Burn Care Res. 2009 Nov-Dec;30(6):910-28. doi: 10.1097/BCR.0b013e3181bfb68f.
- Background: PubMed 22040929Brusselaers N, Logie D, Vogelaers D, Monstrey S, Blot S. Burns, inhalation injury and ventilator-associated pneumonia: value of routine surveillance cultures. Burns. 2012 May;38(3):364-70. doi: 10.1016/j.burns.2011.09.005. Epub 2011 Oct 29.
- Background: PubMed 7673306Rue LW 3rd, Cioffi WG, Mason AD Jr, McManus WF, Pruitt BA Jr. The risk of pneumonia in thermally injured patients requiring ventilatory support. J Burn Care Rehabil. 1995 May-Jun;16(3 Pt 1):262-8. doi: 10.1097/00004630-199505000-00008.
- Background: PubMed 3800465Shirani KZ, Pruitt BA Jr, Mason AD Jr. The influence of inhalation injury and pneumonia on burn mortality. Ann Surg. 1987 Jan;205(1):82-7. doi: 10.1097/00000658-198701000-00015.
- Background: PubMed 24630700Tedja R, Nowacki A, Fraser T, Fatica C, Griffiths L, Gordon S, Isada C, van Duin D. The impact of multidrug resistance on outcomes in ventilator-associated pneumonia. Am J Infect Control. 2014 May;42(5):542-5. doi: 10.1016/j.ajic.2013.12.009. Epub 2014 Mar 14.
- Background: PubMed 25626446Lachiewicz AM, van Duin D, DiBiase LM, Jones SW, Carson S, Rutala WA, Cairns BA, Weber DJ. Rates of hospital-associated respiratory infections and associated pathogens in a regional burn center, 2008-2012. Infect Control Hosp Epidemiol. 2015 May;36(5):601-3. doi: 10.1017/ice.2014.90. Epub 2015 Jan 28. No abstract available.
- Background: PubMed 20597674Craven DE, Hjalmarson KI. Ventilator-associated tracheobronchitis and pneumonia: thinking outside the box. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S59-66. doi: 10.1086/653051.
- Background: PubMed 23221186Sievert DM, Ricks P, Edwards JR, Schneider A, Patel J, Srinivasan A, Kallen A, Limbago B, Fridkin S; National Healthcare Safety Network (NHSN) Team and Participating NHSN Facilities. Antimicrobial-resistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2009-2010. Infect Control Hosp Epidemiol. 2013 Jan;34(1):1-14. doi: 10.1086/668770. Epub 2012 Nov 27.
- BackgroundSiegel 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.
- Background: PubMed 11296184de La Cal MA, Cerda E, Garcia-Hierro P, Lorente L, Sanchez-Concheiro M, Diaz C, van Saene HK. Pneumonia in patients with severe burns : a classification according to the concept of the carrier state. Chest. 2001 Apr;119(4):1160-5. doi: 10.1378/chest.119.4.1160.
- BackgroundAmerican Burn Association. National Burn Repository 2014 Report. Available at http://www.ameriburn.org/2014NBRAnnualReport.pdf. Accessed December 23, 2014.
- University of North Carolina websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Lachiewicz, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-drug Resistant Gram-negative Bacilli Colonization, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653157, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.