- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00514670
A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
August 9, 2007 updated by: Boston Children's Hospital
The objective of the trial is to assess the impact of a disinfection and hand hygiene program on absenteeism in elementary school classrooms.
Students in intervention classrooms will use alcohol-based hand sanitizers at school, and their classrooms will be disinfected using quaternary ammonium wipes.
We hypothesize that the use of disinfectants and hand hygiene products in elementary school classrooms will reduce absenteeism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
285
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Member of a designated elementary school classroom in the Avon school system
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Intervention classrooms received alcohol-based hand sanitizer and disinfecting wipes.
|
|
NO_INTERVENTION: 2
No hand sanitizer or disinfecting wipes were used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absenteeism rate due to gastrointestinal or respiratory illness during the study period.
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bacterial colony counts and the presence of selected viruses on classroom surfaces.
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas J Sandora, MD, MPH, Boston Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion (ACTUAL)
May 1, 2006
Study Registration Dates
First Submitted
August 9, 2007
First Submitted That Met QC Criteria
August 9, 2007
First Posted (ESTIMATE)
August 10, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
August 10, 2007
Last Update Submitted That Met QC Criteria
August 9, 2007
Last Verified
August 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-01-0014
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.
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