Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR).
Scott R Evans, Daniel Rubin, Dean Follmann...
https://pubmed.ncbi.nlm.nih.gov/26113652Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID06258551
Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
Led by The Methodist Hospital Research Institute · Updated on 2024-02-14
1000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Methodist Hospital Research Institute
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study investigates how bacterial populations in the intestines and mouths of immunocompromised and critically ill patients change during their hospital stay. It aims to understand if specific bacteria increase or decrease the risk of infections or colonization by harmful pathogens like vancomycin-resistant enterococci, carbapenem-resistant Enterobacterales, and Clostridium difficile. The research also explores how normal microbiota might protect against these infections, focusing on patients in intensive care and stem cell transplant units. Participants will be recruited from intensive care units and bone marrow transplant units, with no treatments or interventions given as part of the study. During hospitalization, which lasts up to four weeks or until discharge, patients will provide stool samples up to twice a week, weekly blood draws, and weekly oral swabs. Clinical data, including antibiotic exposure and infection status, will be collected from medical records and positive clinical cultures during their stay. Throughout the study period, researchers will monitor clinical outcomes related to colonization and infections using detailed analyses over 30 days. Participants will undergo regular sample collection and have their clinical records reviewed to assess infection risks and outcomes. The overall goal is to understand how bacterial changes impact health in these vulnerable patients during their hospital stay.
CONDITIONS
Brief Title
Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Admission to an intensive care unit or stem cell transplant unit (for allogeneic stem cell transplantation) within previous 24 hours
- Age 18 years or older
You will not qualify if you...
- Younger than 18 years of age
- Pregnancy
- History of inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- Presence of gastrointestinal derivation such as colostomy or ileostomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 24 hours after admission
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Monitoring
Duration - Up to 4 weeks or until discharge from the unit
Participants who are admitted to intensive care or stem cell transplant units are observed to evaluate colonization and infection by multidrug-resistant pathogens through sample collection and clinical data review.
Ongoing sample collection and clinical data review during hospital stay
Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
C
Cesar A Arias, MD, PhD, Msc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Colistin Versus Ceftazidime-Avibactam in the Treatment of Infections Due to Carbapenem-Resistant Enterobacteriaceae.
David van Duin, Judith J Lok, Michelle Earley...
https://pubmed.ncbi.nlm.nih.gov/29020404Intestinal domination and the risk of bacteremia in patients undergoing allogeneic hematopoietic stem cell transplantation.
Ying Taur, Joao B Xavier, Lauren Lipuma...
https://pubmed.ncbi.nlm.nih.gov/22718773Colonization With Levofloxacin-resistant Extended-spectrum β-Lactamase-producing Enterobacteriaceae and Risk of Bacteremia in Hematopoietic Stem Cell Transplant Recipients.
Michael J Satlin, Kalyan D Chavda, Thomas M Baker...
https://pubmed.ncbi.nlm.nih.gov/29701766Distinct but Spatially Overlapping Intestinal Niches for Vancomycin-Resistant Enterococcus faecium and Carbapenem-Resistant Klebsiella pneumoniae.
Silvia Caballero, Rebecca Carter, Xu Ke...
https://pubmed.ncbi.nlm.nih.gov/26334306Acquisition of Carbapenemase-Producing Enterobacteriaceae in Solid Organ Transplantation Recipients.
K H Lee, S H Han, D Yong...
https://pubmed.ncbi.nlm.nih.gov/30577266Is Clostridium difficile infection a risk factor for subsequent bloodstream infection?
Robert J Ulrich, Kavitha Santhosh, Jill A Mogle...
https://pubmed.ncbi.nlm.nih.gov/28669864