Otorhinolaryngologic DiseasesACHEENNCT00948779
Antibiotic Education for Children in an Emergency Care Unit
A study testing antibiotic education for children in an emergency care unit in people with Otorhinolaryngologic Diseases and Respiratory Tract Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Otorhinolaryngologic Diseases, Respiratory Tract Infections, Pyelonephritis
- What is being tested?
- antibiotic education for children in an emergency care unit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Chronic pathology such as: Sickle cell disease, AIDS.
- Parents with insufficient knowledge of French.
- Family not reachable by phone.
- Antibiotic's suspected allergy.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Otorhinolaryngologic Diseases, Respiratory Tract Infections, Pyelonephritis, Urinary Tract Infections
- Being tested
- antibiotic education for children in an emergency care unit
- Keywords
- Patient education, Antibiotic, Child, Respiratory tract infection, Patient satisfaction, Parental knowledge, Adherence
- Medical subject headings
- Otorhinolaryngologic Diseases, Respiratory Tract Infections, Pyelonephritis, Urinary Tract Infections, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic education for children in an emergency care unitOther
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 unitOther
Also called antibiotic education for children an emergency care unit
Educational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: antibiotic education for children in an emergency care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction (likert scale)
Measured: 15 days
Secondary outcomes (1)
Parent's knowledge
Measured: 15 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otorhinolaryngologic DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Angoulvant, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948779
- Sponsor's protocol ID
- ID RCB 2008-A00892-53
- Acronym
- ACHEEN
- Status last verified
- Jul 2012
- First submitted
- 28 Jul 2009
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00948779
- Acronym / sponsor ID
- ACHEEN / ID RCB 2008-A00892-53
- Conditions
- Otorhinolaryngologic Diseases, Respiratory Tract Infections, Pyelonephritis, Urinary Tract Infections
- Keywords
- Patient education, Antibiotic, Child, Respiratory tract infection, Patient satisfaction, Parental knowledge, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibiotics | Other | Other: antibiotic education for children in an emergency care unitantibiotic education for children in an emergency care unit: Patient and family's therapeutic education to improve the use of antibiotics at home. |
| the antipyretic therapy | Experimental | Other: antibiotic education for children in an emergency care unitantibiotic education for children in an emergency care unit: Patient and family's therapeutic education to improve the antipyretic therapy at home. |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Chronic pathology such as: Sickle cell disease, AIDS.
- Parents with insufficient knowledge of French.
- Family not reachable by phone.
- Antibiotic's suspected allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic education for children in an emergency care unitEducational, Behavioral, and Organizational intervention to improve the use of oral antibiotics in children under 6 years | Other | antibiotics |
| antibiotic education for children in an emergency care unitAlso: antibiotic education for children an emergency care unitEducational, Behavioral and Organizational intervention to improve the antipyretic therapy in children under 6 years. | Other | the antipyretic therapy |
Primary outcome
satisfaction (likert scale)
Time frame: 15 days
1 secondary outcome
Parent's knowledge
Time frame: 15 days and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Results publication: PubMed 24086581Angoulvant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Angoulvant, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiotic education for children in an emergency care unit in people with Otorhinolaryngologic Diseases and Respiratory Tract Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfaction (likert scale) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00948779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.