Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
Part of paid clinical trials in Houston, Texas.
- Sponsor
- The Methodist Hospital Research Institute
- Study ID
- NCT06258551
- Status
- Recruiting
Conditions
- Antibiotic Resistant Infection
- Antimicrobial Drug Resistance
- Carbapenem Resistant Bacterial Infection
- Carbapenem-Resistant Enterobacteriaceae Infection
- Clostridium Difficile
- Extended Spectrum Beta-Lactamase Producing Bacteria Infection
- Vancomycin Resistant Enterococci Infection
- Vancomycin-Resistant Enterococcal Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Study Details
The goal of this observational study is to investigate how bacterial populations from the intestine and mouth of patients change during the hospitalization period and evaluate if some populations of specific bacteria increase or decrease the risk of acquiring an infection or becoming colonized by pathogenic bacteria. Participants will have the following samples collected during enrollment: stool samples (maximum 2x/week), blood draws (1x/week), oral swab (1x/week).
Key Dates
- Start date
- Dec 8, 2020
- Status verified
- Feb 2024
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 1,000 participants (estimated)
Arms
- Arm: Intensive Care UnitPatients admitted to an intensive care unit (No interventions administered)
- Arm: Bone Marrow Transplant UnitPatients admitted to a cancer treatment center for allogeneic stem cell transplantation (No interventions administered)
Primary Outcome Measure
Impact of Colonization on Clinical Outcomes Using DOOR Analysis [ Time Frame: 30 days ]
Central Contacts
- Cesar A Arias, MD, PhD, Msc346-238-4870
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | Cesar A Arias, MD, PhD, Msc (PRINCIPAL_INVESTIGATOR) |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 |
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