An observational study in Multidrug-resistant Colonization, sponsored by National Institutes of Health Clinical Center (CC). Enrolling by invitation at 1 site in United States. Open to participants aged 2 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by National Institutes of Health Clinical Center (CC) · Observational
Background:
- The intestines, mouth, and skin all contain billions of bacteria and some fungi. Every person s body contains microorganisms like these. They normally do not make people sick. Researchers are interested in how these microorganisms change when a person is hospitalized. They want to find out if changes take place because of the hospitalization (such as treatments used or changes in medical condition) or because of a person s biology (such as their immune system).
Objectives:
- To understand which microorganisms are most likely to spread through hospitals and what affects that spread.
Eligibility:
- People 2 years of age and older who are going to be inpatients at the National Institutes of Health Clinical Center (NIHCC) for at least 48 hours.
Design:
The goal of this protocol is to explore changes to microbial communities during the course of hospitalcare, and to determine the extent to which these alterations affect whether hospitalized patients become colonized with healthcare-associated organisms. The study enables collection of clinical specimens and associated medical data to evaluate the natural history, epidemiology, and genomics of patients who might become colonized or infected with a multidrug-resistant organism. Biological specimens including stool, sputum, and swabs will be taken from Clinical Center inpatients at least 2 years of age as frequently as daily through discharge, and at follow-up visits for up to 2 years from the date of enrollment. To understand possible pathogen colonization and infection of hospitalized patients, this protocol will assess the full complement of the microbial-host-environmental contributions including: (1) microbial genome and community;(2) patient s genotype, underlying medical condition, medical treatment; and (3) hospital practices and environment.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's planned enrollment of 250 is below the median of 351 across 115 observational studies indexed under Cross Infection.
Browse Cross Infection studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals hospitalized at the Clinical Center
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals must meet the following inclusion criteria to participate in the study:
EXCLUSION CRITERIA:
A patient will not be eligible if he/she has any condition which, in the investigator s opinion, places the patient at undue risk by participating in the study.
Patients who might become colonized or infected with a multidrug-resistant organism
The primary endpoint is to accumulate a sufficiently robust body of intestinal microbiome data and clinical and epidemiological metadata to characterize fully the changes in the human microbiota that occur during the course of hospitalization an...
Once sufficient microbiome data and clinical and epidemiological meta data is collected we will be able to fully characterize the changes in the human microbiota that occur during the course if hospitalization
Time frame: At completion of study
Determine the features of microbiota that may render patients vulnerable to or protect patients from colonization with MDROs.
Time frame: At completion of study
Determine clinical correlates of MDRO colonization and infection
Time frame: At completion of study
Detect the presence of MDROs in biological samples obtained from participants.
Time frame: At completion of study
Plan to share: Undecided
Started Jan 2014 (actual). Primary completion is estimated for Oct 2028, 176 months after the start.
Of 56 non-industry observational studies under Cross Infection, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's planned 176 months is above that.
Counting every sponsor, half of 56 studies reached it within 28 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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National Institutes of Health Clinical Center (CC) →