Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital

NCT02948335 | Completed

• 1 other identifier: NVIROM
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Microbial communities; Hospital environment; Disinfection; Adenosine triphosphate measures; Bioburden

Outcome Measures

Primary Outcomes (2)

• Change in diversity index of environment microbial composition

  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

  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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and their nursing staff and caregivers admitted to the Kay Research and Care Center inpatient unit.

You may qualify if:

• 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.

You may not qualify if:

• Inability or unwillingness of participant or legal guardian/representative to give written informed consent.
• 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.
• Inability or unwillingness of primary caregiver to give informed consent.
• Nurse assigned to patient participant on the day of patient participant sample collection
• Willing to provide informed consent
• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Infections

Study Officials

• Hana Hakim, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 28, 2016
• Study Start: February 23, 2017
• Primary Completion: February 19, 2018
• Study Completion: February 19, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

US (1)