Respiratory InfectionsNCT00514670
A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
A study testing Alcohol-based hand sanitizer & quaternary ammonium wipes in people with Respiratory Infections and Gastrointestinal Diseases, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Infections, Gastrointestinal Diseases
- What is being tested?
- Alcohol-based hand sanitizer & quaternary ammonium wipes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to May 2006
- Phase
- Interventional
- 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
Who may be able to join
- Member of a designated elementary school classroom in the Avon school system
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
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.
- Conditions
- Respiratory Infections, Gastrointestinal Diseases
- Being tested
- Alcohol-based hand sanitizer & quaternary ammonium wipes
- Keywords
- Prevention of gastrointestinal and respiratory illness
- Medical subject headings
- Respiratory Tract Infections, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-based hand sanitizer & quaternary ammonium wipesOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention classrooms received alcohol-based hand sanitizer and disinfecting wipes. Receives: Other: Alcohol-based hand sanitizer & quaternary ammonium wipes |
| 2 | No intervention | No hand sanitizer or disinfecting wipes were used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absenteeism rate due to gastrointestinal or respiratory illness during the study period.
Measured: 8 weeks
Secondary outcomes (1)
Bacterial colony counts and the presence of selected viruses on classroom surfaces.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startMar 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionsStudies of the same condition, open and under way.
- More trials run by Boston Children's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Study funds provided by The Clorox Company
- Investigators
- Thomas J Sandora, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514670
- Sponsor's protocol ID
- 06-01-0014
- Status last verified
- Aug 2007
- First submitted
- 9 Aug 2007
- Last updated
- 10 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Sandora TJ, Shih MC, Goldmann DA. Reducing absenteeism from gastrointestinal and respiratory illness in elementary school students: a randomized, controlled trial of an infection-control intervention. Pediatrics. 2008 Jun;121(6):e1555-62. doi: 10.1542/peds.2007-2597.
PubMed 18519460
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
- ClinicalTrials.gov ID
- NCT00514670
- Acronym / sponsor ID
- 06-01-0014
- Conditions
- Respiratory Infections, Gastrointestinal Diseases
- Keywords
- Prevention of gastrointestinal and respiratory illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Study funds provided by The Clorox Company
- Study start
- Mar 2006
- Study completion
- May 2006 (actual)
- First posted
- 10 Aug 2007 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Alcohol-based hand sanitizer & quaternary ammonium wipesIntervention classrooms received alcohol-based hand sanitizer and disinfecting wipes. |
| 2 | No intervention | –No hand sanitizer or disinfecting wipes were used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Member of a designated elementary school classroom in the Avon school system
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol-based hand sanitizer & quaternary ammonium wipes | Other | 1 |
Primary outcome
Absenteeism rate due to gastrointestinal or respiratory illness during the study period.
Time frame: 8 weeks
1 secondary outcome
Bacterial colony counts and the presence of selected viruses on classroom surfaces.
Time frame: 8 weeks
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 10 Aug 2007.
- Derived from this study: PubMed 18519460Sandora TJ, Shih MC, Goldmann DA. Reducing absenteeism from gastrointestinal and respiratory illness in elementary school students: a randomized, controlled trial of an infection-control intervention. Pediatrics. 2008 Jun;121(6):e1555-62. doi: 10.1542/peds.2007-2597.
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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.
Thomas J Sandora, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol-based hand sanitizer & quaternary ammonium wipes in people with Respiratory Infections and Gastrointestinal Diseases, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2007. 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?
Absenteeism rate due to gastrointestinal or respiratory illness during the study period. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514670, which also lists 1 linked publication.
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 10 Aug 2007.