Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258551
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-06
Brief Title:
Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
Sponsor:
The Methodist Hospital Research Institute
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Dynamics of Colonization and Infection by Multidrug-Resistant Pathogens in Immunocompromised and Critically Ill Patients
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYNAMITE
Brief Summary:
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 2xweek blood draws 1xweek oral swab 1xweek
Detailed Description:
The objectives of this study are to dissect the main microbial clinical and antimicrobial resistance determinants that impact colonization and infection by vancomycin-resistant enterococci VRE extended-spectrum beta-lactamase producing Enterobacterales ESBL-E carbapenem-resistant Enterobacterales CRE and Clostridium difficile to evaluate the role of commensal microbiota in VRE ESBL-ECRE and C difficile colonization and to define the functional aspects of keystone microbiota and mechanisms of protection against colonizationinfection
Patients will be recruited from both intensive care units n500 and stem cell transplant units n500 and will be followed until discharge from these units or for a maximum of four weeks In addition to stool blood and oral samples enrolled patients will have clinical data collected by chart review to evaluate colonizationinfection-related clinical status microbiological laboratory information exposure to antibiotics and clinical outcomes Positive clinical cultures taken during the course of hospitalization will also be collected for analysis
Patients will be recruited from both intensive care units n500 and stem cell transplant units n500 and will be followed until discharge from these units or for a maximum of four weeks In addition to stool blood and oral samples enrolled patients will have clinical data collected by chart review to evaluate colonizationinfection-related clinical status microbiological laboratory information exposure to antibiotics and clinical outcomes Positive clinical cultures taken during the course of hospitalization will also be collected for analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P01AI152999-01 | NIH | None | httpsreporternihgovquickSearch1P01AI152999-01 |