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

Primary Purpose

Otorhinolaryngologic Diseases, Respiratory Tract Infections, Pyelonephritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
antibiotic education for children in an emergency care unit
antibiotic education for children in an emergency care unit
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Otorhinolaryngologic Diseases focused on measuring Patient education, Antibiotic, Child, Respiratory tract infection, Patient satisfaction, Parental knowledge, Adherence

Eligibility Criteria

1 Month - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Robert Debré

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

antibiotics

the antipyretic therapy

Arm Description

antibiotic education for children in an emergency care unit: Patient and family's therapeutic education to improve the use of antibiotics at home.

antibiotic education for children in an emergency care unit: Patient and family's therapeutic education to improve the antipyretic therapy at home.

Outcomes

Primary Outcome Measures

satisfaction (likert scale)

Secondary Outcome Measures

Parent's knowledge

Full Information

First Posted
July 28, 2009
Last Updated
February 1, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00948779
Brief Title
Antibiotic Education for Children in an Emergency Care Unit
Acronym
ACHEEN
Official Title
Therapeutic Education About Intake of Oral Solutions of Antibiotics in Children Under 6 Year-old at the Emergency Department in Robert Debré Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otorhinolaryngologic Diseases, Respiratory Tract Infections, Pyelonephritis, Urinary Tract Infections
Keywords
Patient education, Antibiotic, Child, Respiratory tract infection, Patient satisfaction, Parental knowledge, Adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
antibiotics
Arm Type
Other
Arm Description
antibiotic education for children in an emergency care unit: Patient and family's therapeutic education to improve the use of antibiotics at home.
Arm Title
the antipyretic therapy
Arm Type
Experimental
Arm Description
antibiotic education for children in an emergency care unit: Patient and family's therapeutic education to improve the antipyretic therapy at home.
Intervention Type
Other
Intervention Name(s)
antibiotic education for children in an emergency care unit
Intervention Description
Educational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years
Intervention Type
Other
Intervention Name(s)
antibiotic education for children in an emergency care unit
Other Intervention Name(s)
antibiotic education for children an emergency care unit
Intervention Description
Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.
Primary Outcome Measure Information:
Title
satisfaction (likert scale)
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Parent's knowledge
Time Frame
15 days and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Angoulvant, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24086581
Citation
Angoulvant F, Rouault A, Prot-Labarthe S, Boizeau P, Skurnik D, Morin L, Mercier JC, Alberti C, Bourdon O. Randomized controlled trial of parent therapeutic education on antibiotics to improve parent satisfaction and attitudes in a pediatric emergency department. PLoS One. 2013 Sep 26;8(9):e75590. doi: 10.1371/journal.pone.0075590. eCollection 2013.
Results Reference
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Antibiotic Education for Children in an Emergency Care Unit

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