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CompletedNCT00948779ACHEENUpdated Feb 3, 2023

Antibiotic Education for Children in an Emergency Care Unit

An interventional study of antibiotic education for children in an emergency care unit and antibiotic education for children in an emergency care unit in Otorhinolaryngologic Diseases, Respiratory Tract Infections and Pyelonephritis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 1 Month to 6 Years. Per ClinicalTrials.gov, last updated 2023-02-03.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
1 Month to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Otorhinolaryngologic Diseases
  • Respiratory Tract Infections
  • Pyelonephritis
  • Urinary Tract Infections

Keywords

  • Patient education
  • Antibiotic
  • Child
  • Respiratory tract infection
  • Patient satisfaction
  • Parental knowledge
  • Adherence
03

Who can participate

Ages eligible
1 Month to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Otherantibiotic 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

  • Otherantibiotic education for children in an emergency care unit

    Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.

    Also known as: antibiotic education for children an emergency care unit

05

What researchers measure

Primary outcomes

  1. satisfaction (likert scale)

    Time frame: 15 days

Secondary outcomes

  1. Parent's knowledge

    Time frame: 15 days and 6 months

06

Study locations

1 site
  • Hôpital Robert Debré
    Paris, 75019, France
07

References and documents

Publications

  • 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. PubMed 24086581 ↗
08

Registry details

Key details

Study ID
NCT00948779
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jul 29, 2009
Start date
Feb 2009
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Feb 3, 2023

Study contacts

François Angoulvant, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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