Upper Respiratory InfectionsPhase 4NCT01728090
Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
A Phase 4 study testing hand sanitizer in people with Upper Respiratory Infections and Influenza, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental.
Trial summary
The aim of the study was to assess the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. Students in intervention classrooms used hand sanitizers at schools and a programme educational on hand hygiene. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Upper Respiratory Infections, Influenza, Common Cold
- What is being tested?
- hand sanitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,640 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to May 2010
- Phase
- Phase 4
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools,
- The parents/tutors signed an agreement after being informed of its content.
Who cannot join
- Children with absenteeism due to a different cause from upper respiratory infections
- Children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school
- Children whose parents did not authorise their participation in the study.
About this study
The aim of the study was to assess the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. Students in intervention classrooms used hand sanitizers at schools and a programme educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in elementary school will reduce absenteeism due to upper respiratory infections.
Read the detailed description
School absenteeism due to respiratory infections is one of the greatest problems in schools. Its high incidence and easy transmission among pupils have a great impact requiring a vast number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments, symptomatic medication, etc. besides being a cause for school absenteeism and time off work for parents. Hand- washing is the most important and effective measure to prevent the transmission of infections. The investigators evaluated the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections.
A cluster randomised, controlled and open study of 2 cohorts of primary school children between the ages of 4 and 12, attending 5 Public Schools in a geographic area of the Almería province (Spain). This study was carried out throughout the 8 months of an academic year (October 2009 to May 2010). The experimental group washed their hands with soap and water, complemented with hand sanitizer, while the control group followed usual hand washing. The parents of both groups completed the survey on sociodemographic characteristics and questions about hand hygiene referred to when and how their children wash their hands Progenitors of children who were absent from school collected upper respiratory infections symptoms and handed in the completed form to the teacher. One Research assistant collected the absence sheets of the participating classes weekly, telephoned the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in hand hygiene related activities.
- Conditions
- Upper Respiratory Infections, Influenza, Common Cold
- Being tested
- hand sanitizer
- Keywords
- handwashing, hand sanitizer, absenteeism, school age children, preschool children
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand sanitizerOther
Also called ALCO ALOE GEL
alcohol-based, hydroalcoholic gel
| Study group | Role | What they receive |
|---|---|---|
| Hand sanitizer | Experimental | Intervention classrooms received alcohol-based hand sanitizer and a programme educational.
Characteristics of the hydroalcoholic gel (ALCO ALOE GEL): chlorhexidine digluconate at 20% solution, phenoxyethanol 1%, benzalkonium chloride 0.%. aloe Barbadensis 5%, Renat ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 65 - 70% degrees, pondus Hydrogenium (pH) = 7-7,5. Receives: Other: hand sanitizer |
| Control | No intervention | No hand sanitizer or educational programme were used |
What is being measured
The primary outcome is the main question the study is designed to answer.
School absenteeism rate caused by upper respiratory infection
The incidence rate of respiratory infections was calculated dividing the number of episodes respiratory by the number of pupils during the period of this study who were susceptible to the infection.
Incidence rate ratio indicates (IRR): the ratio between incidence rate in both study groups.
Measured: One academic year (eight months follow-up)
Secondary outcomes (1)
Average duration of absence
The average duration of absence per child was calculated dividing the number of absence days due to respiratory infection by the total number of children during that period.
Measured: One academic year (eight months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory InfectionsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Spain
- Responsible party
- Principal investigator, Ernestina Azor Martínez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
- Investigators
- Ernestina Azor, MD, PhD, Principal investigator, Department of Health of Andalusia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728090
- Sponsor's protocol ID
- PI 0388/2008
- Status last verified
- Nov 2012
- First submitted
- 13 Nov 2012
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
- ClinicalTrials.gov ID
- NCT01728090
- Acronym / sponsor ID
- PI 0388/2008
- Conditions
- Upper Respiratory Infections, Influenza, Common Cold
- Keywords
- handwashing, hand sanitizer, absenteeism, school age children, preschool children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,640 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalUniversity, hospital or other
- Collaborators
- Ministry of Health, Spain
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 16 Nov 2012 (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 aim of the study was to assess the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. Students in intervention classrooms used hand sanitizers at schools and a programme educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in elementary school will reduce absenteeism due to upper respiratory infections.
Detailed description
School absenteeism due to respiratory infections is one of the greatest problems in schools. Its high incidence and easy transmission among pupils have a great impact requiring a vast number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments, symptomatic medication, etc. besides being a cause for school absenteeism and time off work for parents. Hand- washing is the most important and effective measure to prevent the transmission of infections. The investigators evaluated the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections.
A cluster randomised, controlled and open study of 2 cohorts of primary school children between the ages of 4 and 12, attending 5 Public Schools in a geographic area of the Almería province (Spain). This study was carried out throughout the 8 months of an academic year (October 2009 to May 2010). The experimental group washed their hands with soap and water, complemented with hand sanitizer, while the control group followed usual hand washing. The parents of both groups completed the survey on sociodemographic characteristics and questions about hand hygiene referred to when and how their children wash their hands Progenitors of children who were absent from school collected upper respiratory infections symptoms and handed in the completed form to the teacher. One Research assistant collected the absence sheets of the participating classes weekly, telephoned the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in hand hygiene related activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand sanitizer | Experimental | Other: hand sanitizerIntervention classrooms received alcohol-based hand sanitizer and a programme educational. Characteristics of the hydroalcoholic gel (ALCO ALOE GEL): chlorhexidine digluconate at 20% solution, phenoxyethanol 1%, benzalkonium chloride 0.%. aloe Barbadensis 5%, Renat ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 65 - 70% degrees, pondus Hydrogenium (pH) = 7-7,5. |
| Control | No intervention | –No hand sanitizer or educational programme were used |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- School children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools,
- The parents/tutors signed an agreement after being informed of its content.
Key exclusion criteria (3 listed)
- Children with absenteeism due to a different cause from upper respiratory infections
- Children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school
- Children whose parents did not authorise their participation in the study.
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 |
|---|---|---|
| hand sanitizerAlso: ALCO ALOE GELalcohol-based, hydroalcoholic gel | Other | Hand sanitizer |
Primary outcome
School absenteeism rate caused by upper respiratory infection
Time frame: One academic year (eight months follow-up)
The incidence rate of respiratory infections was calculated dividing the number of episodes respiratory by the number of pupils during the period of this study who were susceptible to the infection. Incidence rate ratio indicates (IRR): the ratio between incidence rate in both study groups.
1 secondary outcome
Average duration of absence
Time frame: One academic year (eight months follow-up)
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 19 Nov 2012.
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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.
Ernestina Azor, MD, PhD principal investigator
Department of Health of Andalusia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hand sanitizer in people with Upper Respiratory Infections and Influenza, run by Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental.
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 2 inclusion and 3 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 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
School absenteeism rate caused by upper respiratory infection (time frame: One academic year (eight months follow-up)). 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 19 Nov 2012.