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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948335
• Other study ID #: NVIROM
• Status: Completed
• Start date: February 23, 2017
• Est. completion date: February 19, 2018

Study information

• Verified date: August 2018
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 19, 2018
• Est. primary completion date: February 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infection

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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