- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948779
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
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
-
-
-
Paris, France, 75019
- Hopital Robert Debre
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-
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.
|
Educational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years
Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.
Other Names:
|
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.
|
Educational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years
Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.
Other Names:
|
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
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15 days and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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
- Pathologic Processes
- Respiratory Tract Diseases
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Nephritis
- Nephritis, Interstitial
- Pyelitis
- Emergencies
- Infections
- Communicable Diseases
- Urinary Tract Infections
- Respiratory Tract Infections
- Pyelonephritis
- Otorhinolaryngologic Diseases
- Anti-Infective Agents
- Antitubercular Agents
- Anti-Bacterial Agents
- Antibiotics, Antitubercular
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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