Investigating bacterial changes in immunocompromised patients during hospitalization
Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
This study looks at how the bacteria in the intestines and mouths of immunocompromised patients change while they are in the hospital to see if these changes affect their risk of infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT06258551 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how bacterial populations in the intestines and mouths of immunocompromised and critically ill patients change throughout their hospital stay. It will evaluate the impact of specific bacterial populations on the risk of acquiring infections or becoming colonized by pathogenic bacteria. Participants will provide stool samples, blood draws, and oral swabs at regular intervals, and clinical data will be collected to assess their health status and outcomes. The study focuses on understanding the role of commensal microbiota in relation to various antibiotic-resistant infections.
Who should consider this trial
Good fit: Ideal candidates include adults admitted to intensive care units or stem cell transplant units within the last 24 hours.
Not a fit: Patients under 18 years of age, pregnant individuals, or those with a history of inflammatory bowel disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing infections in vulnerable patient populations.
How similar studies have performed: Other studies have shown success in understanding microbial dynamics in similar patient populations, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admission to an intensive care unit or stem cell transplant unit (for allogeneic stem cell transplantation) within previous 24 hours Exclusion Criteria: * \<18 years of age * Pregnancy * History of inflammatory bowel disease (Crohn's disease, ulcerative colitis) * Gastrointestinal derivation (colostomy, ileostomy, etc.)
Where this trial is running
Houston, Texas and 1 other locations
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Cesar A Arias, MD, PhD, Msc — The Methodist Hospital Research Institute
- Study coordinator: Cesar A Arias, MD, PhD, Msc
- Email: CAArias@Houstonmethodist.org
- Phone: 346-238-4870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.