ClinicalTrials.gg
RecruitingNCT05210543Updated Aug 21, 2024

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

An observational study in Anaphylaxis, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Charite University, Berlin, Germany · Observational

From the registry’s dates

  • Started Jan 2007; still recruiting 19 years 10 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20,000
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Anaphylaxis

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03

In context

Anaphylaxis

100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 137 across 48 observational studies indexed under Anaphylaxis.

Browse Anaphylaxis studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Anaphylactic reaction within the past 12 months

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Anaphylactic reaction (observational)

    Patients who experienced an anaphylactic reaction will be observed

    Other: not applicable, observational study

Interventions

  • Othernot applicable, observational study

    Patients do not receive intervention; observational study

06

What researchers measure

Primary outcomes

  1. Influence of risk factors

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

    Time frame: 10 years

Secondary outcomes

  1. Epiphenomenon

    Correlation between epiphenomenoa of the anaphylaxis and the frequency of allergic reactions

    Time frame: 10 years

  2. Current use of adrenaline

    Assessment of acute treatments with adrenaline

    Time frame: 10 years

  3. Future use of adrenaline

    Comparison of the frequencies of the use of adrenaline from beginning to end of the observation

    Time frame: 10 years

  4. Country-specific differences in anaphylaxis handling

    Comparison of the triggers, diagnosis, treatment and prophylaxis of anaphylactic reactions throughout different countries

    Time frame: 10 years

  5. Biomarkers

    Identification of biomarkers (e.g. PGE2 via ELISA, Tryptase via ImmunoCAP) for anaphylactic reactions

    Time frame: 10 years

  6. Epigenetics

    Correlation of genetic and epigenetic factors with the pathogenesis of severe allergic reactions

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2007 (actual). Primary completion is estimated for Dec 2030, 287 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2022
First posted
Jan 27, 2022
StartActual
Jan 1, 2007
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Aug 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05210543
Responsible party
Margitta Worm (Principal Investigator, Charite University, Berlin, Germany) — Principal investigator
First posted
Jan 27, 2022
Start date
Jan 1, 2007
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Aug 21, 2024

Study contacts

Margitta Worm, Prof.
Contact
margitta.worm@charite.de
+49 30 450 518105
Sabine Dölle-Bierke, PhD
Contact
sabine.doelle@charite.de
+49 30 450 518367
Margitta Worm, Prof.
study chair · Charite University, Berlin, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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