Vaccination FailureExt EBUGNCT03683732
EXTENSION OF THE EUROPEAN E-BUG PROJECT
An observational study of Vaccination Failure, run by Centre Hospitalier Universitaire de Nice.
Trial summary
Bacterial resistance to antibiotics is a growing concern in Europe, vaccination coverage is inadequate, and young adults, who are the highest antibiotic consumers, have the lowest level of knowledge. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccination Failure
- What is being tested?
- Individual semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 5 Dec 2013
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The recrutement and the conversations were realized on a voluntary basis in the crossroads health young people of Nice, structure dedicated to the grown-up young adolescentset from 12 to 25 years old.
Who may be able to join
- 15-18 year olds, various origines, studying in various pathways of higher secondary education or working.
Who cannot join
- -
About this study
Official title: EXTENSION OF THE EUROPEAN E-BUG PROJECT TOWARDS 15-18 YEARS - How to Raise Awareness About Antibiotics and Vaccination Among Frenchteenagers -
Bacterial resistance to antibiotics is a growing concern in Europe, vaccination coverage is inadequate, and young adults, who are the highest antibiotic consumers, have the lowest level of knowledge. Extension of the e-Bug project, a European educational school programme concerning microbes, antibiotics and vaccination, to 15-18-year-olds implies the development of educational resources based on social marketing to promote sustainable behavioural changes. The objectives of the present study, which is part of the needs assessment in France, are to explore the attitudes, knowledge and behaviour of 15-18-year-olds concerning antibiotics and vaccination and their health education needs.
Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed.
- Conditions
- Vaccination Failure
- Being tested
- Individual semi-structured interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual semi-structured interviewsBehavioural
Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed
| Study group | Role | What they receive |
|---|---|---|
| Frenchteenagers | Not described Receives: Behavioral: Individual semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior concerning antibiotics and vaccination
questionnary (no scale) used to Explore attitudes, behavior and knowledge of the 15-18-year-old young people in France concerning antibiotics and vaccination . Data collection by means of a questionnary during a unique interview with the teenager.
Measured: 5 years
Secondary outcomes (1)
Expectation and media
questionnary (no scale) used to Determine the expectations of the 15-18-year-old young people in France and needs concerning the methods and the supports of education. Data collection by means of a questionnary during a unique interview with the teenager
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Mar 2013
- Primary completion31 May 2013
- Study completion5 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pia Touboul, Dr, Study chair, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683732
- Sponsor's protocol ID
- 18-DSP-02
- Acronym
- Ext EBUG
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXTENSION OF THE EUROPEAN E-BUG PROJECT TOWARDS 15-18 YEARS - How to Raise Awareness About Antibiotics and Vaccination Among Frenchteenagers -
- ClinicalTrials.gov ID
- NCT03683732
- Acronym / sponsor ID
- Ext EBUG / 18-DSP-02
- Conditions
- Vaccination Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 5 Dec 2013 (actual)
- First posted
- 25 Sep 2018 (actual)
- 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.
Bacterial resistance to antibiotics is a growing concern in Europe, vaccination coverage is inadequate, and young adults, who are the highest antibiotic consumers, have the lowest level of knowledge. Extension of the e-Bug project, a European educational school programme concerning microbes, antibiotics and vaccination, to 15-18-year-olds implies the development of educational resources based on social marketing to promote sustainable behavioural changes. The objectives of the present study, which is part of the needs assessment in France, are to explore the attitudes, knowledge and behaviour of 15-18-year-olds concerning antibiotics and vaccination and their health education needs.
Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frenchteenagers | – | Behavioral: Individual semi-structured interviews |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The recrutement and the conversations were realized on a voluntary basis in the crossroads health young people of Nice, structure dedicated to the grown-up young adolescentset from 12 to 25 years old.
Key inclusion criteria (1 listed)
- 15-18 year olds, various origines, studying in various pathways of higher secondary education or working.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Individual semi-structured interviewsIndividual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed | Behavioural | Frenchteenagers |
Primary outcome
Behavior concerning antibiotics and vaccination
Time frame: 5 years
questionnary (no scale) used to Explore attitudes, behavior and knowledge of the 15-18-year-old young people in France concerning antibiotics and vaccination . Data collection by means of a questionnary during a unique interview with the teenager.
1 secondary outcome
Expectation and media
Time frame: 5 years
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 27 Sep 2018.
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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.
Pia Touboul, Dr study chair
Centre Hospitalier Universitaire de Nice
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination Failure, run by Centre Hospitalier Universitaire de Nice.
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 1 inclusion and 1 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 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Behavior concerning antibiotics and vaccination (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2018.