Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT02948335
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2016-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital
Status:
COMPLETED
Status Verified Date:
2018-08
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:
None
Brief Summary:
Microorganisms that colonize hospital environments play an important role in the transmission of hospital acquired infections (HAI) and multi-drug resistant organisms. Previous studies examining microorganisms in the hospital environment have been limited by reliance on targeted culture-based methods resulting in potentially missed or unrecognized organisms. Evidence now suggests that using microbiome analysis offers an innovative strategy that may improve our understanding of HAI and how best to prevent them.
This pilot longitudinal observational study aims to characterize the taxonomic composition of microbial communities on environmental surfaces and people in these environments prior to and following the introduction of patients, caregiver, and hospital staff to newly constructed inpatient care areas at St. Jude Children's Research Hospital (SJCRH). This proposed study is uniquely characterized by evaluating the hospital environment of a pediatric immunocompromised oncology patient population that has not been studied in the past using advanced molecular techniques such as microbiome analysis.
PRIMARY OBJECTIVE:
* To describe the pattern of microbial communities of the hospital environment before, during and after patient occupancy of a newly constructed hospital space.
SECONDARY OBJECTIVES:
* To describe the similarity or difference of environment microbial communities to that of the humans occupying this environment in a newly occupied hospital space.
* To describe the pattern in environment microbial communities after each step of disinfection (manual cleaning with chemical disinfectant and Ultraviolet light disinfection machine) after patient discharge from the inpatient hospital environment.
* To evaluate the correlation between environmental Adenosine Triphosphate (ATP) measures and organism bioburden.
This pilot longitudinal observational study aims to characterize the taxonomic composition of microbial communities on environmental surfaces and people in these environments prior to and following the introduction of patients, caregiver, and hospital staff to newly constructed inpatient care areas at St. Jude Children's Research Hospital (SJCRH). This proposed study is uniquely characterized by evaluating the hospital environment of a pediatric immunocompromised oncology patient population that has not been studied in the past using advanced molecular techniques such as microbiome analysis.
PRIMARY OBJECTIVE:
* To describe the pattern of microbial communities of the hospital environment before, during and after patient occupancy of a newly constructed hospital space.
SECONDARY OBJECTIVES:
* To describe the similarity or difference of environment microbial communities to that of the humans occupying this environment in a newly occupied hospital space.
* To describe the pattern in environment microbial communities after each step of disinfection (manual cleaning with chemical disinfectant and Ultraviolet light disinfection machine) after patient discharge from the inpatient hospital environment.
* To evaluate the correlation between environmental Adenosine Triphosphate (ATP) measures and organism bioburden.
Detailed Description:
Participants will be recruited from the patient population at SJCRH. Patients admitted to one of the protocol defined inpatient rooms in the Kay Research and Care Center (KRCC) will be enrolled on the study. Participating patients will be asked to provide stool, nasal swab, and skin swab samples while inpatient. Primary caregivers and the nurse assigned to the patient's room will also be asked to provide nasal and skin swabs while the patient remains inpatient. These samples will be used to characterize the human microbiome for comparison to the environmental microbiome.
Study Oversight
Has Oversight DMC:
False
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?: