Antibiotic Education for Children in an Emergency Care Unit (ACHEEN)

July 26, 2012 updated by: Assistance Publique - Hôpitaux de Paris

Therapeutic Education About Intake of Oral Solutions of Antibiotics in Children Under 6 Year-old at the Emergency Department in Robert Debré Hospital

The purpose of this study is to determine if a patient education in acute condition about the intake of oral solution antibiotic in children under 6 year-old are effective to improve the satisfaction about the therapeutic education, the knowledge about antibiotics among the patients' families and thereby decrease the misuses of antibiotics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adherence to antibiotic regimen for common childhood illnesses, such as otitis media and streptococcal pharyngitis, is related to a variety of outcomes such as illness' remission, prevention of recurrent infections, maintaining of cost-effectiveness, and prevention of the growth of antibiotic-resistance. A patient and family 's therapeutic education about the intake of an oral solution of antibiotic should decrease the misuses of antibiotic, improve the family 's knowledge and the satisfaction of the patient and his family. Those factors are related to the understanding and adherence to the antibiotic prescription.

Study Type

Interventional

Enrollment (Actual)

300

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

  • France
      • Paris, France, 75019
        • Hopital Robert Debre

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

1 month to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • French-speaking patients seen at the emergency department and discharged with a diagnosis of bacterial infections (urinary and respiratory tract infections, streptococcal pharyngitis, acute otitis media) requiring 5 to 10 days of an oral solution of antibiotic.
  • Under 6 year-old.
  • No opposition of the parents to be included in the study.
  • Personal health insurance.

Exclusion Criteria:

  • Chronic pathology such as: Sickle cell disease, AIDS.
  • Parents with insufficient knowledge of French.
  • Family not reachable by phone.
  • Antibiotic's suspected allergy.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: antibiotics
antibiotic education for children in an emergency care unit: Patient and family's therapeutic education to improve the use of antibiotics at home.
Other: antibiotic education for children in an emergency care unit
Educational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years
Other: antibiotic education for children in an emergency care unit
Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.
Other Names:
  • antibiotic education for children an emergency care unit
Experimental: the antipyretic therapy
antibiotic education for children in an emergency care unit: Patient and family's therapeutic education to improve the antipyretic therapy at home.
Other: antibiotic education for children in an emergency care unit
Educational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years
Other: antibiotic education for children in an emergency care unit
Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.
Other Names:
  • antibiotic education for children an emergency care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
satisfaction (likert scale)
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Parent's knowledge
Time Frame: 15 days and 6 months
15 days and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: François Angoulvant, MD, Assistance Publique - Hôpitaux de Paris

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.

General Publications

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

February 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 28, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Estimate)

July 27, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID RCB 2008-A00892-53

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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