NCT05210543

Brief Summary

The Anaphylaxis Registry aims to assess data in a standardized form about symptoms, triggers, cofactors and therapy management from patients who experienced an anaphylactic reaction. This should improve diagnosis and long-term management of these life-threatening allergic reactions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress81%
Jan 2007Dec 2030

Study Start

First participant enrolled

January 1, 2007

Completed
15 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

23.9 years

First QC Date

January 14, 2022

Last Update Submit

August 20, 2024

Conditions

Anaphylaxis

Outcome Measures

Primary Outcomes (1)

  • Influence of risk factors

    Correlation between risk factors (age, epiphenomenon, comorbidity) and severity of anaphylaxis

    10 years

Secondary Outcomes (6)

  • Epiphenomenon

    10 years

  • Current use of adrenaline

    10 years

  • Future use of adrenaline

    10 years

  • Country-specific differences in anaphylaxis handling

    10 years

  • Biomarkers

    10 years

  • +1 more secondary outcomes

Study Arms (1)

Anaphylactic reaction (observational)

Patients who experienced an anaphylactic reaction will be observed

Other: not applicable, observational study

Interventions

not applicable, observational studyOTHER

Patients do not receive intervention; observational study

Anaphylactic reaction (observational)

Eligibility Criteria

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

Subjects who experienced a severe anaphylactic reaction and presenting in a participating center

You may qualify if:

  • Anaphylactic reaction within the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

option for Blood sampling (Serum, Blood cells, Cytokines, Biomarkers)

MeSH Terms

Conditions

Anaphylaxis

Interventions

Observation

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Margitta Worm, Prof.

    Charite University, Berlin, Germany

    STUDY CHAIR

Central Study Contacts

Margitta Worm, Prof.

CONTACT

+49 30 450 518105margitta.worm@charite.de

Sabine Dölle-Bierke, PhD

CONTACT

+49 30 450 518367sabine.doelle@charite.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 27, 2022

Study Start

January 1, 2007

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations

DE(1)