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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00948779
Other study ID # ID RCB 2008-A00892-53
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2009
Est. completion date March 2012

Study information

Verified date July 2012
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 1 Month to 6 Years
Eligibility 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 Design


Intervention

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
antibiotic education for children in an emergency care unit
Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.

Locations

Country Name City State
France Hôpital Robert Debré Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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 dep — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary satisfaction (likert scale) 15 days
Secondary Parent's knowledge 15 days and 6 months
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