<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01728090</url>
  </required_header>
  <id_info>
    <org_study_id>PI 0388/2008</org_study_id>
    <nct_id>NCT01728090</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections</brief_title>
  <official_title>Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to assess the effectiveness of a hand-washing programme using hand&#xD;
      sanitizer in the prevention of school absenteeism due to upper respiratory infections.&#xD;
      Students in intervention classrooms used hand sanitizers at schools and a programme&#xD;
      educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in&#xD;
      elementary school will reduce absenteeism due to upper respiratory infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      School absenteeism due to respiratory infections is one of the greatest problems in schools.&#xD;
      Its high incidence and easy transmission among pupils have a great impact requiring a vast&#xD;
      number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments,&#xD;
      symptomatic medication, etc. besides being a cause for school absenteeism and time off work&#xD;
      for parents. Hand- washing is the most important and effective measure to prevent the&#xD;
      transmission of infections. The investigators evaluated the effectiveness of a hand-washing&#xD;
      programme using hand sanitizer in the prevention of school absenteeism due to upper&#xD;
      respiratory infections.&#xD;
&#xD;
      A cluster randomised, controlled and open study of 2 cohorts of primary school children&#xD;
      between the ages of 4 and 12, attending 5 Public Schools in a geographic area of the Almería&#xD;
      province (Spain). This study was carried out throughout the 8 months of an academic year&#xD;
      (October 2009 to May 2010). The experimental group washed their hands with soap and water,&#xD;
      complemented with hand sanitizer, while the control group followed usual hand washing. The&#xD;
      parents of both groups completed the survey on sociodemographic characteristics and questions&#xD;
      about hand hygiene referred to when and how their children wash their hands Progenitors of&#xD;
      children who were absent from school collected upper respiratory infections symptoms and&#xD;
      handed in the completed form to the teacher. One Research assistant collected the absence&#xD;
      sheets of the participating classes weekly, telephoned the parents of absent children to&#xD;
      enquire about the cause of their absence, visited the classrooms and collaborated with the&#xD;
      teachers in hand hygiene related activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">May 2010</completion_date>
  <primary_completion_date type="Actual">May 2010</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>School absenteeism rate caused by upper respiratory infection</measure>
    <time_frame>One academic year (eight months follow-up)</time_frame>
    <description>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.&#xD;
Incidence rate ratio indicates (IRR): the ratio between incidence rate in both study groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average duration of absence</measure>
    <time_frame>One academic year (eight months follow-up)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1640</enrollment>
  <condition>Upper Respiratory Infections</condition>
  <condition>Influenza</condition>
  <condition>Common Cold</condition>
  <arm_group>
    <arm_group_label>Hand sanitizer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention classrooms received alcohol-based hand sanitizer and a programme educational.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No hand sanitizer or educational programme were used</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>hand sanitizer</intervention_name>
    <description>alcohol-based, hydroalcoholic gel</description>
    <arm_group_label>Hand sanitizer</arm_group_label>
    <other_name>ALCO ALOE GEL</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  School children between the ages of 4 and 12 years old, enrolled in the above&#xD;
             mentioned public schools,&#xD;
&#xD;
          -  The parents/tutors signed an agreement after being informed of its content.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Children with absenteeism due to a different cause from upper respiratory infections&#xD;
&#xD;
          -  Children with chronic illnesses that could affect their likelihood of contracting an&#xD;
             infection or the duration of their period of absence from school&#xD;
&#xD;
          -  Children whose parents did not authorise their participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ernestina Azor, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Health of Andalusia</affiliation>
  </overall_official>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 16, 2012</last_update_submitted>
  <last_update_submitted_qc>November 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental</investigator_affiliation>
    <investigator_full_name>Ernestina Azor Martínez</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>handwashing</keyword>
  <keyword>hand sanitizer</keyword>
  <keyword>absenteeism</keyword>
  <keyword>school age children</keyword>
  <keyword>preschool children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Common Cold</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hand Sanitizers</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01728090
org study id: PI 0388/2008
nct id: NCT01728090
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: School absenteeism rate caused by upper respiratory infection
time frame: One academic year (eight months follow-up)
description: 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.
measure: Average duration of absence
time frame: One academic year (eight months follow-up)
description: 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.
arm group label: Hand sanitizer
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: No Intervention
description: No hand sanitizer or educational programme were used
intervention type: Other
intervention name: hand sanitizer
description: alcohol-based, hydroalcoholic gel
arm group label: Hand sanitizer
other name: ALCO ALOE GEL
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: No
last name: Ernestina Azor, MD, PhD
role: Principal Investigator
affiliation: Department of Health of Andalusia
responsible party type: Principal Investigator
investigator affiliation: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
investigator full name: Ernestina Azor Martínez
investigator title: MD, PhD
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Common Cold
mesh term: Hand Sanitizers