NCT05112367

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

October 27, 2021

Last Update Submit

October 27, 2021

Conditions

Keywords

ChildrenEmergencyEpinephrine

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    day 1

Secondary Outcomes (2)

  • Evaluation of an appropriate use of epinephrine

    day 1

  • Evaluation of an appropriate use of a possible follow-up of patients after the episode

    day 1

Eligibility Criteria

Age2 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children consulting in the paediatric emergency department of Montpellier for suspected allergy from 2016 to 2020

You may qualify if:

  • Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
  • Children consulting for suspected allergy from 2016 to 2020

You may not qualify if:

  • \- Patients under legal protection, under guardianship or under curatorship;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

AnaphylaxisHypersensitivityEmergencies

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Davide CAIMMI

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Davide CAIMMI, MD

CONTACT

Evangéline CLARK, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2021

First Posted

November 8, 2021

Study Start

October 1, 2021

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

November 8, 2021

Record last verified: 2021-10

Locations