NCT00963391

Brief Summary

The purpose of this study is to conduct a Randomized Control Trial (RCT) in a developing country setting in order to evaluate the role of alcohol based hand sanitizers (ABHS) in preventing the transmission of infectious diseases in areas where water is a scarce resource. The investigators want to find out if the use of ABHS reduces the incidence of two leading causes of morbidity and mortality in children under 5 years of age in the developing world: acute diarrheal disease (ADD) and acute respiratory infections (ARI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,727

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

Enrollment Period

10 months

First QC Date

August 20, 2009

Last Update Submit

August 20, 2009

Conditions

Acute Diarrheal DiseaseAcute Respiratory Infection

Keywords

Health ProductionGovernment Policy; Regulation; Public HealthGovernment Policy; Provision and Effects of Welfare ProgramsGastrointestinal diseasesRespiratory Tract InfectionsDiarrheaEthanolChild, PreschoolHandwashing

Outcome Measures

Primary Outcomes (1)

  • Number of Cases of Acute Diarrheal Disease Number of Cases of Acute Respiratory Infection

    April - December 2008

Secondary Outcomes (1)

  • Number of Adverse Events

    April - December 2008

Study Arms (2)

ABHS use

EXPERIMENTAL

Centers assigned to the intervention group were provided with ABHS dispensers with a gel solution with ethyl alcohol at 62% as active ingredient (Purell®, GOJO Industries, Dayton, Ohio). Proper safety measures were followed. Standardized ABHS training workshops for staff and children in centers allocated to the intervention were carried out simultaneously with dispenser installation. Thirty minute refresher sessions about ABHS technique were provided to staff and children on a monthly basis, for a total of 8 sessions per center.

Other: ABHS use

No treatment

NO INTERVENTION

Centers assigned to the control group received no hand hygiene recommendations other than to continue with current hand hygiene practices and no further information on hand hygiene other than the general information received before trial initiation was provided.

Interventions

ABHS useOTHER

Centers assigned to the intervention group were provided with ABHS dispensers with a gel solution with ethyl alcohol at 62% as active ingredient (Purell®, GOJO Industries, Dayton, Ohio). A total of 85 dispensers were installed, one dispenser was installed in each center of size less than 14 children, and one per classroom plus an additional one for common areas in centers with more than 28 children. Proper safety measures were followed. Standardized ABHS training workshops for staff and children in centers allocated to the intervention were carried out simultaneously with dispenser installation. Thirty minute refresher sessions about ABHS technique were provided to staff and children on a monthly basis, for a total of 8 sessions per center.

Also known as: Purell®, GOJO Industries, Dayton, Ohio
ABHS use

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between 1 and 5 years of age
  • Attending child care centers with limited tap water availability

You may not qualify if:

  • Chronic conditions
  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Santa Fe de Bogotá

Bogotá, D.C., Colombia

Location

MeSH Terms

Conditions

Gastrointestinal DiseasesRespiratory Tract InfectionsDiarrhea

Condition Hierarchy (Ancestors)

Digestive System DiseasesInfectionsRespiratory Tract DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juan C Correa, MD

    Fundación Santa Fe de Bogotá

    PRINCIPAL INVESTIGATOR

  • Diana Pinto, MD

    Fedesarrollo, Pontificia Universidad Javeriana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

February 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

CO(1)