AnaphylaxisAna-PedNCT05112367
Epidemiology and Management of Pediatric Anaphylaxis and Allergy in the Pediatric Emergency Department of Montpellier
An observational study of Anaphylaxis and Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. Read more about this study
- Who is it for?
- Ages 2 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis, Allergy
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 1 Jun 2022
- 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 2 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children consulting in the paediatric emergency department of Montpellier for suspected allergy from 2016 to 2020
Who may be able to join
- Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
- Children consulting for suspected allergy from 2016 to 2020
Who cannot join
- Patients under legal protection, under guardianship or under curatorship;
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Davide CAIMMI, MD, 467336112 ext. 33, davide.caimmi@gmail.com
About this study
Official title: Retrospective Study on the Management of Pediatric Anaphylaxis and Clinical Signs of Allergy in the Pediatric Emergency Department of Montpellier University Hospital
Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital
- Conditions
- Anaphylaxis, Allergy
- Keywords
- Children, Emergency, Epinephrine
- Medical subject headings
- Anaphylaxis, Hypersensitivity, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the management of pediatric anaphylaxis of allergy
Evaluation of the management of pediatric anaphylaxis of allergy in the pediatric emergency department of Montpellier University Hospital.
Measured: day 1
Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital.
Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital.
Measured: day 1
Secondary outcomes (2)
Evaluation of an appropriate use of epinephrine
Evaluation of an appropriate use of epinephrine
Measured: day 1
Evaluation of an appropriate use of a possible follow-up of patients after the episode
Evaluation of an appropriate use of a possible follow-up of patients after the episode
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
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 AnaphylaxisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide CAIMMI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112367
- Sponsor's protocol ID
- RECHMPL21_0613
- Acronym
- Ana-Ped
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Clark E, Kase Tanno L, Vo T, Blanc B, Demoly P, Caimmi D. Anaphylaxis management in a French pediatric emergency department: Lessons from the ANA-PED study. Clin Transl Allergy. 2023 Aug;13(8):e12289. doi: 10.1002/clt2.12289.
PubMed 37632240
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study on the Management of Pediatric Anaphylaxis and Clinical Signs of Allergy in the Pediatric Emergency Department of Montpellier University Hospital
- ClinicalTrials.gov ID
- NCT05112367
- Acronym / sponsor ID
- Ana-Ped / RECHMPL21_0613
- Conditions
- Anaphylaxis, Allergy
- Keywords
- Children, Emergency, Epinephrine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 8 Nov 2021 (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 a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children consulting in the paediatric emergency department of Montpellier for suspected allergy from 2016 to 2020
Key inclusion criteria (2 listed)
- Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
- Children consulting for suspected allergy from 2016 to 2020
Key exclusion criteria (1 listed)
- Patients under legal protection, under guardianship or under curatorship;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the management of pediatric anaphylaxis of allergy
Time frame: day 1
Evaluation of the management of pediatric anaphylaxis of allergy in the pediatric emergency department of Montpellier University Hospital.
Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital.
Time frame: day 1
Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital.
2 secondary outcomes
Evaluation of an appropriate use of epinephrine
Time frame: day 1
Evaluation of an appropriate use of a possible follow-up of patients after the episode
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Derived from this study: PubMed 37632240Clark E, Kase Tanno L, Vo T, Blanc B, Demoly P, Caimmi D. Anaphylaxis management in a French pediatric emergency department: Lessons from the ANA-PED study. Clin Transl Allergy. 2023 Aug;13(8):e12289. doi: 10.1002/clt2.12289.
- Individual participant dataSharing planned: Undecided. NC
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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.
Davide CAIMMI study director
University Hospital, Montpellier
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 Allergy, run by University Hospital, Montpellier 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 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide CAIMMI, MD (467336112 ext. 33, davide.caimmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the management of pediatric anaphylaxis of allergy (time frame: day 1). The study lists 2 primary outcomes in all. 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 NCT05112367, 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 8 Nov 2021.