NCT00948779

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 3, 2023

Status Verified

July 1, 2012

Enrollment Period

3.1 years

First QC Date

July 28, 2009

Last Update Submit

February 1, 2023

Conditions

Keywords

Patient educationAntibioticChildRespiratory tract infectionPatient satisfactionParental knowledgeAdherence

Outcome Measures

Primary Outcomes (1)

  • satisfaction (likert scale)

    15 days

Secondary Outcomes (1)

  • Parent's knowledge

    15 days and 6 months

Study Arms (2)

antibiotics

OTHER

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

the antipyretic therapy

EXPERIMENTAL

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

Interventions

Educational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years

antibiotics

Eligibility Criteria

Age1 Month - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Otorhinolaryngologic DiseasesRespiratory Tract InfectionsPyelonephritisUrinary Tract InfectionsPatient Satisfaction

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesNephritis, InterstitialNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPyelitisMale Urogenital DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • François Angoulvant, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 3, 2023

Record last verified: 2012-07

Locations