InfectionNCT02948335
Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital
An observational study of Infection, run by St. Jude Children's Research Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2017to 19 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients and their nursing staff and caregivers admitted to the Kay Research and Care Center inpatient unit.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Infection
- Keywords
- Microbial communities, Hospital environment, Disinfection, Adenosine triphosphate measures, Bioburden
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before participant admission to after participant discharge, which is up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start23 Feb 2017
- Primary completion19 Feb 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hana Hakim, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948335
- Sponsor's protocol ID
- NVIROM
- Status last verified
- Aug 2018
- First submitted
- 18 Oct 2016
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions of Environmental and Human Microbial Communities in a Pediatric Oncology Hospital
- ClinicalTrials.gov ID
- NCT02948335
- Acronym / sponsor ID
- NVIROM
- Conditions
- Infection
- Keywords
- Microbial communities, Hospital environment, Disinfection, Adenosine triphosphate measures, Bioburden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients and their nursing staff and caregivers admitted to the Kay Research and Care Center inpatient unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hana Hakim, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diversity index of environment microbial composition (time frame: Before participant admission to after participant discharge, which is up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.