AnaphylaxisSAPRANCT03942692
What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction
An observational study of Anaphylaxis and Allergic Reaction, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Anaphylaxis is an allergic reaction potentially fatal. The treatment is based on injection of epinephrin as soon as possible. Guidelines by the World Allergic Organisation highlight the importance of medical follow-up. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anaphylaxis, Allergic Reaction
- What is being tested?
- Phone call questionnaire
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2019to 20 Aug 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children from 0 to 18 year old who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France.
Who may be able to join
- Age from 0 to 17
- Anaphylactic reaction meeting the criteria of Sampson et al. treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France
- Anaphylactic reaction treated between the 1st July 2014 and the 31st June 2016
Who cannot join
- No agreement from patient or parents to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Paediatric Emergency Department in Femme-Mère-Enfant Hospital
Bron, 69677
About this study
Anaphylaxis is an allergic reaction potentially fatal. The treatment is based on injection of epinephrin as soon as possible. Guidelines by the World Allergic Organisation highlight the importance of medical follow-up. This follow-up consists of an allergy consultation, the prescription and demonstration of epinephrin auto-injector and the implementation of specific measures in schools. There is no study about the recurrence of anaphylactic reaction outside the hospital.
The purpose of this study is to evaluate the allergy follow-up of children after anaphylactic reaction. The secondary objective is to evaluate the use of medical advice in case of recurrence of anaphylactic reaction.
Investigators will use a phone call questionnaire for parents of children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in the Paediatric Emergency Department in Femme-Mère-Enfant Hospital in Lyon in France. 179 children could be included in the study.
- Conditions
- Anaphylaxis, Allergic Reaction
- Being tested
- Phone call questionnaire
- Medical subject headings
- Anaphylaxis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone call questionnaireOther
Questionnaire for parents of subject about :
- the frequency of consultations with an allergist
- the information of the general practitioner or pediatrician
- the prescription of epinephrin auto-injector
- the frequency of renewal of epinephrin auto-injector
- the specialty of doctor who prescribed the renewal
- the implementation of specific measures in schools
- the frequency of renewal of specific measures in schools
- the number of recurrence of anaphylactic reaction
- the use of medical advice in case of recurrence of anaphylactic reaction
| Study group | Role | What they receive |
|---|---|---|
| Children with anaphylactic reaction | Children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France. Receives: Other: Phone call questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergy follow-up
Allergy follow-up evaluation with :
- the frequency of consultations with an allergist
- the information of the general practitioner or pediatrician
- the prescription of epinephrin auto-injector
- the frequency of renewal of epinephrin auto-injector
- the specialty of doctor who prescribed the renewal
- the implementation of specific measures in schools
- the frequency of renewal of specific measures in schools
- the number of recurrence of anaphylactic reaction
- the use of medical advice in case of recurrence of anaphylactic reaction
Measured: About 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start21 May 2019
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942692
- Sponsor's protocol ID
- 69HCL18_0493
- Acronym
- SAPRA
- Status last verified
- Oct 2019
- First submitted
- 7 May 2019
- Last updated
- 9 Oct 2019
- 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 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction
- ClinicalTrials.gov ID
- NCT03942692
- Acronym / sponsor ID
- SAPRA / 69HCL18_0493
- Conditions
- Anaphylaxis, Allergic Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 8 May 2019 (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.
Anaphylaxis is an allergic reaction potentially fatal. The treatment is based on injection of epinephrin as soon as possible. Guidelines by the World Allergic Organisation highlight the importance of medical follow-up. This follow-up consists of an allergy consultation, the prescription and demonstration of epinephrin auto-injector and the implementation of specific measures in schools. There is no study about the recurrence of anaphylactic reaction outside the hospital.
The purpose of this study is to evaluate the allergy follow-up of children after anaphylactic reaction. The secondary objective is to evaluate the use of medical advice in case of recurrence of anaphylactic reaction.
Investigators will use a phone call questionnaire for parents of children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in the Paediatric Emergency Department in Femme-Mère-Enfant Hospital in Lyon in France. 179 children could be included in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with anaphylactic reaction | – | Other: Phone call questionnaireChildren who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children from 0 to 18 year old who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France.
Key inclusion criteria (3 listed)
- Age from 0 to 17
- Anaphylactic reaction meeting the criteria of Sampson et al. treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France
- Anaphylactic reaction treated between the 1st July 2014 and the 31st June 2016
Key exclusion criteria (1 listed)
- No agreement from patient or parents to participate in the study
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 |
|---|---|---|
| Phone call questionnaireQuestionnaire for parents of subject about : * the frequency of consultations with an allergist * the information of the general practitioner or pediatrician * the prescription of epinephrin auto-injector * the frequency of renewal of epinephrin auto-injector * the specialty of doctor who prescribed the renewal * the implementation of specific measures in schools * the frequency of renewal of specific measures in schools * the number of recurrence of anaphylactic reaction * the use of medical advice in case of recurrence of anaphylactic reaction | Other | Children with anaphylactic reaction |
Primary outcome
Allergy follow-up
Time frame: About 15 minutes
Allergy follow-up evaluation with : * the frequency of consultations with an allergist * the information of the general practitioner or pediatrician * the prescription of epinephrin auto-injector * the frequency of renewal of epinephrin auto-injector * the specialty of doctor who prescribed the renewal * the implementation of specific measures in schools * the frequency of renewal of specific measures in schools * the number of recurrence of anaphylactic reaction * the use of medical advice in case of recurrence of anaphylactic reaction
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 9 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis and Allergic Reaction, run by Hospices Civils de Lyon 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 3 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 9 Oct 2019. 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?
Allergy follow-up (time frame: About 15 minutes). 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 9 Oct 2019.