Acquisition and Long-term Observation of Patients With Severe Allergic Reactions

Anaphylaxis Clinical Trial

Official title:

Acquisition and Long-term Observation of Patients With Severe Allergic Reactions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210543
• Other study ID #: Anaphylaxis Registry
• Status: Recruiting
• Start date: January 1, 2007
• Est. completion date: December 2030

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: Margitta Worm, Prof.
• Phone: +49 30 450 518105
• Email: margitta.worm[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

A better understanding of the triggers and pathology of anaphylactic reactions could lead to a better diagnosis and prophylaxis to avoid the occurence of these life-threatening allergic reactions. This can be an advantage for affected persons regarding the their treatment and long-term management.

The Anaphylaxis Registry is an opportunity to gather these standardized data. The blood sampling is optional for the patient, however, it will contribute to the better understanding of the sensitization profile and possible mechanisms. Recent publications showed a correlation between an anaphylactic reaction and certain biomarkers. Those data will be validated in a larger number of population with identification of further biomarkers. It is presumed that certain genetic and epigenetic polymorphisms are abundant for patients who experienced an anaphylaxis.

To summarize, this study aims to contribute to a better understanding of the anaphylaxis in general, the diagnosis, and the prognosis with different severities. With the identification of a certain trigger, the obtained understanding may help to decrease the risk of or prevent future repeating reactions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Anaphylactic reaction within the past 12 months

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anaphylaxis
• Hypersensitivity

Intervention

Other:
• not applicable, observational study
Patients do not receive intervention; observational study

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of risk factors	Correlation between risk factors (age, epiphenomenon, comorbidity) and severity of anaphylaxis	10 years
Secondary	Epiphenomenon	Correlation between epiphenomenoa of the anaphylaxis and the frequency of allergic reactions	10 years
Secondary	Current use of adrenaline	Assessment of acute treatments with adrenaline	10 years
Secondary	Future use of adrenaline	Comparison of the frequencies of the use of adrenaline from beginning to end of the observation	10 years
Secondary	Country-specific differences in anaphylaxis handling	Comparison of the triggers, diagnosis, treatment and prophylaxis of anaphylactic reactions throughout different countries	10 years
Secondary	Biomarkers	Identification of biomarkers (e.g. PGE2 via ELISA, Tryptase via ImmunoCAP) for anaphylactic reactions	10 years
Secondary	Epigenetics	Correlation of genetic and epigenetic factors with the pathogenesis of severe allergic reactions	10 years