- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02948335
Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Patient Participant Inclusion Criteria:
- Patients scheduled to be admitted or admitted to SJCRH,
- Admitted to one of the protocol defined inpatient rooms in the KRCC building at SJCRH,
- Patient, parents or legal guardian willing and able to provide informed consent and comply with study requirements,
- When applicable, participant is willing to provide assent and comply with the study requirements.
Patient Participant Exclusion Criteria:
- Inability or unwillingness of participant or legal guardian/representative to give written informed consent.
Primary Caregiver Participant Inclusion Criteria
- Primary caregiver anticipated to provide care for patient while he or she is inpatient at St. Jude Children's Research Hospital,
- ≥ 18 years old,
- Able and willing to provide informed consent and comply with study requirements.
Primary Caregiver Participant Exclusion Criteria
- Inability or unwillingness of primary caregiver to give informed consent.
- Primary Nurse Participant Inclusion Criteria
- Nurse assigned to patient participant on the day of patient participant sample collection
- Willing to provide informed consent
Primary Nurse Participant Exclusion Criteria
- Inability or unwillingness to provide informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in diversity index of environment microbial composition
Time Frame: Before participant admission to after participant discharge, which is up to 30 days
|
Microbial flora colonizing a newly built hospital environment will be compared prior to participant inpatient admission to after inpatient hospital discharge.
Microbiome diversity is a measure of the richness of microbial species present in the environmental sample.
It is reported as diversity index.
|
Before participant admission to after participant discharge, which is up to 30 days
|
Change in microbiome composition within the environment microbial composition
Time Frame: Before participant admission to after participant discharge, which is up to 30 days
|
Microbial flora colonizing a newly built hospital environment will be compared prior to participant inpatient admission to after inpatient hospital discharge.
Microbiome composition describes which bacteria are detected in a sample.
It is reported as percentage of relative abundance of each taxa of bacteria.
|
Before participant admission to after participant discharge, which is up to 30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hana Hakim, MD, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NVIROM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infection
-
Radboud University Medical CenterSint MaartenskliniekActive, not recruitingSurgical Site Infection | Joint Infection | Infection, Surgical Site | Infection Prosthesis Hip and Knee | Infection, Prosthesis Related | Infection ProNetherlands
-
West Virginia UniversityEnrolling by invitationSkin and Soft Tissue Infection | Gastrointestinal Infection | Pulmonary Infection | Bone and Joint Infection | Endovascular Infection | Genitourinary InfectionUnited States
-
Ondine Biomedical Inc.CompletedSurgical Site Infection | Nosocomial Infection | Healthcare Associated InfectionUnited States
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site Infection | Superficial Surgical Site Infection | Deep Surgical Site Infection | Organ/Space Surgical Site InfectionUnited States
-
Croydon Health Services NHS TrustCompletedSurgical Site Infection | Wound Infection | Cesarean Section; Infection | Perineal InfectionUnited Kingdom
-
Cairo UniversityRecruitingPostoperative Infection | Cesarean Section Complications | Vaginal InfectionEgypt
-
Vastra Gotaland RegionGöteborg UniversityRecruitingProsthetic Joint Infection | Hip Prosthesis Infection | Prosthetic Infection | Knee Prosthesis InfectionSweden
-
University of ZurichRecruitingProsthetic Joint Infection | Surgical Site Infection | Prosthesis and Implants | Postoperative Wound Infection Deep Incisional Surgical SiteSwitzerland
-
Ondine Biomedical Inc.CompletedNosocomial Infection | Surgical Site Infections | Healthcare Associated InfectionsUnited States
-
Angela BiancoStryker NordicTerminatedCesarean Section | Surgical Site Infection | Nosocomial InfectionUnited States