AnaphylaxisNCT05210543
Acquisition and Long-term Observation of Patients With Severe Allergic Reactions
An observational study of Anaphylaxis, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anaphylaxis
- What is being tested?
- not applicable, observational study
- How many people
- 20,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2007to Dec 2030
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who experienced a severe anaphylactic reaction and presenting in a participating center
Who may be able to join
- Anaphylactic reaction within the past 12 months
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Margitta Worm, Prof., +49 30 450 518105, margitta.worm@charite.de
Sabine Dölle-Bierke, PhD, +49 30 450 518367, sabine.doelle@charite.de
About this study
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.
- Conditions
- Anaphylaxis
- Being tested
- not applicable, observational study
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not applicable, observational studyOther
Patients do not receive intervention; observational study
| Study group | Role | What they receive |
|---|---|---|
| Anaphylactic reaction (observational) | Patients who experienced an anaphylactic reaction will be observed Receives: Other: not applicable, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of risk factors
Correlation between risk factors (age, epiphenomenon, comorbidity) and severity of anaphylaxis
Measured: 10 years
Secondary outcomes (6)
Epiphenomenon
Correlation between epiphenomenoa of the anaphylaxis and the frequency of allergic reactions
Measured: 10 years
Current use of adrenaline
Assessment of acute treatments with adrenaline
Measured: 10 years
Future use of adrenaline
Comparison of the frequencies of the use of adrenaline from beginning to end of the observation
Measured: 10 years
Country-specific differences in anaphylaxis handling
Comparison of the triggers, diagnosis, treatment and prophylaxis of anaphylactic reactions throughout different countries
Measured: 10 years
Biomarkers
Identification of biomarkers (e.g. PGE2 via ELISA, Tryptase via ImmunoCAP) for anaphylactic reactions
Measured: 10 years
Epigenetics
Correlation of genetic and epigenetic factors with the pathogenesis of severe allergic reactions
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jan 2007
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (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 Charite University, Berlin, GermanyThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margitta Worm, Charite University, Berlin, Germany
- Investigators
- Margitta Worm, Prof., Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210543
- Sponsor's protocol ID
- Anaphylaxis Registry
- Status last verified
- Aug 2024
- First submitted
- 14 Jan 2022
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Almaci M, Treudler R, Breiding M, Kohli A, Lange L, Pfohler C, Vogelberg C, Worm M. Allergen immunotherapy-induced anaphylaxis: Data from the European Anaphylaxis Registry. Ann Allergy Asthma Immunol. 2025 Jun;134(6):724-730. doi: 10.1016/j.anai.2025.02.012. Epub 2025 Feb 22.
PubMed 39993472
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition and Long-term Observation of Patients With Severe Allergic Reactions
- ClinicalTrials.gov ID
- NCT05210543
- Acronym / sponsor ID
- Anaphylaxis Registry
- Conditions
- Anaphylaxis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Jan 2022 (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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anaphylactic reaction (observational) | – | Other: not applicable, observational studyPatients who experienced an anaphylactic reaction will be observed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who experienced a severe anaphylactic reaction and presenting in a participating center
Key inclusion criteria (1 listed)
- Anaphylactic reaction within the past 12 months
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not applicable, observational studyPatients do not receive intervention; observational study | Other | Anaphylactic reaction (observational) |
Primary outcome
Influence of risk factors
Time frame: 10 years
Correlation between risk factors (age, epiphenomenon, comorbidity) and severity of anaphylaxis
6 secondary outcomes
Epiphenomenon
Time frame: 10 years
Current use of adrenaline
Time frame: 10 years
Future use of adrenaline
Time frame: 10 years
Country-specific differences in anaphylaxis handling
Time frame: 10 years
Biomarkers
Time frame: 10 years
Epigenetics
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 39993472Almaci M, Treudler R, Breiding M, Kohli A, Lange L, Pfohler C, Vogelberg C, Worm M. Allergen immunotherapy-induced anaphylaxis: Data from the European Anaphylaxis Registry. Ann Allergy Asthma Immunol. 2025 Jun;134(6):724-730. doi: 10.1016/j.anai.2025.02.012. Epub 2025 Feb 22.
- Individual participant dataSharing planned: Undecided
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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.
Margitta Worm, Prof. study chair
Charite University, Berlin, Germany
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, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margitta Worm, Prof. (+49 30 450 518105, margitta.worm@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of risk factors (time frame: 10 years). 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 NCT05210543, 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 21 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.