Antibiotic Education for Children in an Emergency Care Unit - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00948779

Purpose

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.

Condition	Intervention
Otorhinolaryngologic Diseases Respiratory Tract Infections Pyelonephritis Urinary Tract Infections	Other: antibiotic education for children in an emergency care unit

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Emergency Medical Services Urinary Tract Infections

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

satisfaction (likert scale) [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Parent's knowledge [ Time Frame: 15 days and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
antibiotics Patient and family's therapeutic education to improve the use of antibiotics at home.	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 Other Name: antibiotic education for children in an emergency care unit
Experimental: the antipyretic therapy Patient and family's therapeutic education to improve the antipyretic therapy at home.	Other: antibiotic education for children in an emergency care unit Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years. Other Name: antibiotic education for children an emergency care unit

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.

Eligibility

Ages Eligible for Study:	1 Month to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948779

Contacts

Contact: Olivier Bourdon, PD,PHD	+33 1 40 03 53 36	olivier.bourdon@rdb.aphp.fr
Contact: Anne Rouault	+ 33 1 40 03 40 44	anne.rouault@rdb.aphp.fr

Locations

France
Hôpital Robert Debré	Recruiting
Paris, France, 75019
Principal Investigator: François Angoulvant, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

François Angoulvant, MD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00948779 History of Changes
Other Study ID Numbers:	ID RCB 2008-A00892-53
Study First Received:	July 28, 2009
Last Updated:	October 31, 2011
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Patient education
Antibiotic
Child
Respiratory tract infection

Patient satisfaction
Parental knowledge
Adherence

Additional relevant MeSH terms:

Emergencies
Otorhinolaryngologic Diseases
Pyelonephritis
Respiratory Tract Infections
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Nephritis, Interstitial
Nephritis
Kidney Diseases

Urologic Diseases
Pyelitis
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Antipyretics
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012