Anaphylactic ReactionPhase 4SAFARINCT07341776
Steroid Use in Treatment of Allergic Reactions to Food
A Phase 4 study testing Antihistamines, Systemic corticosteroids and Adrenaline (rescue medication) in people with Anaphylactic Reaction and Anaphylaxis, run by Johannes Trueck at 2 sites in Switzerland.
Trial summary
In this study, the investigators want to find out whether a specific medication commonly used for severe allergic reactions is really necessary. When children have allergic reactions to foods, they are often given medications to relieve the symptoms. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Anaphylactic Reaction, Anaphylaxis, Allergy in Children
- What is being tested?
- Antihistamines, Systemic corticosteroids and Adrenaline (rescue medication)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 26 Jan 2026to Dec 2026
- Phase
- Phase 4
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- suspected or confirmed IgE-mediated food allergy
Who cannot join
- Non-IgE mediated food allergies
- Non-food allergies
- Age outside the specified range
- Contraindications for an oral food challenge or oral steroid use within one week before the challenge.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Children's Hospital Basel
Basel, Basel, 4031
Felicitas Bellutti Enders, Dr. med. PhD, +41 61 704 2770, felicitas.belluttienders@ukbb.ch
- Recruiting
University Children's Hospital, Zürich
Zurich, Canton of Zurich, 8008
Johannes Trück, PD Dr. med. DPhil, +41 44 249 49 49, johannes.trueck@kispi.uzh.ch
About this study
Official title: Evaluation of Emergency Medication in Children With Food Allergies: a Prospective, Randomized Clinical Multicenter Study Comparing Antihistamines Versus Antihistamines Plus Steroids in a Controlled Setting of Oral Food Challenges in Children.
In this study, the investigators want to find out whether a specific medication commonly used for severe allergic reactions is really necessary. When children have allergic reactions to foods, they are often given medications to relieve the symptoms. In addition to adrenaline and antihistamines, steroids are frequently administered in German-speaking Switzerland. However, it is unclear whether steroids are really helpful in this situation. To investigate this, the investigators are comparing two groups: one group receives additional steroids, and the other does not. Which treatment a participant receives is decided randomly, like flipping a coin. The study takes place during a pre-scheduled provocation test at the clinic. If an allergic reaction occurs, the usual emergency medications will be administered. Doctors will closely monitor how the reaction develops. No additional tests or visits are required. The results of this study could help improve allergy treatment in the future.
- Being tested
- Antihistamines, Systemic corticosteroids, Adrenaline (rescue medication)
- Medical subject headings
- Anaphylaxis, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntihistaminesDrug
Also called Dimetindene maleate, Levocetirizine
Oral administration of antihistamines for treatment of allergic symptoms during the oral food challenge.
Systemic corticosteroidsDrug
Also called Betamethasone, Prednisolone
Oral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge.
Adrenaline (rescue medication)Drug
Also called Adrenaline
Intramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Antihistamines plus oral steroids | Active comparator | Participants receive oral antihistamines plus oral systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated. Receives: Drug: Antihistamines; Drug: Systemic corticosteroids; Drug: Adrenaline (rescue medication) |
| Antihistamines only (no steroids) | Active comparator | Participants receive oral antihistamines without systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated. Receives: Drug: Antihistamines; Drug: Adrenaline (rescue medication) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete resolution of allergic symptoms
Time from onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, comparing treatment with antihistamines alone versus antihistamines plus oral steroids.
Measured: From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.
Secondary outcomes (6)
Total number of adrenaline doses and cumulative adrenaline dose
Total number of intramuscular adrenaline administrations and cumulative adrenaline dose administered per participant for treatment of allergic reactions during the oral food challenge.
Measured: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.
Total number of antihistamine doses and cumulative antihistamine dose
Total number of oral antihistamine administrations and cumulative antihistamine dose administered per participant for treatment of allergic reactions during the oral food challenge.
Measured: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.
Severity of allergic reaction
Severity of allergic reactions assessed using PRACTALL consensus definitions and documented on a standardized monitoring form during the oral food challenge.
Measured: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.
Hospitalization and intensive care unit admission
Occurrence of hospitalization or admission to an intensive care unit (ICU) for management of allergic reactions occurring during the oral food challenge.
Measured: From onset of allergic reaction during the oral food challenge until hospital discharge or end of observation period, assessed up to 24 hours.
Time from onset of allergic symptoms to patient discharge
Time from onset of allergic symptoms leading to discontinuation of the oral food challenge until discharge from hospital or outpatient unit.
Measured: From onset of allergic symptoms during the oral food challenge until patient discharge, assessed up to 24 hours.
Late-phase allergic reactions
Occurrence of late-phase allergic reactions, defined as recurrence or worsening of allergic symptoms after complete resolution of the initial reaction, without further allergen exposure, following treatment during the oral food challenge.
Measured: From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start26 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaphylactic ReactionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Trueck
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Sponsor-investigator, Johannes Trueck, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341776
- Sponsor's protocol ID
- BASEC-2025-00320
- Other IDs
- HumRes67580, SNCTP000006696
- Acronym
- SAFARI
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Emergency Medication in Children With Food Allergies: a Prospective, Randomized Clinical Multicenter Study Comparing Antihistamines Versus Antihistamines Plus Steroids in a Controlled Setting of Oral Food Challenges in Children.
- ClinicalTrials.gov ID
- NCT07341776
- Acronym / sponsor ID
- SAFARI / BASEC-2025-00320
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Johannes TrueckUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jan 2026 (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.
In this study, the investigators want to find out whether a specific medication commonly used for severe allergic reactions is really necessary. When children have allergic reactions to foods, they are often given medications to relieve the symptoms. In addition to adrenaline and antihistamines, steroids are frequently administered in German-speaking Switzerland. However, it is unclear whether steroids are really helpful in this situation. To investigate this, the investigators are comparing two groups: one group receives additional steroids, and the other does not. Which treatment a participant receives is decided randomly, like flipping a coin. The study takes place during a pre-scheduled provocation test at the clinic. If an allergic reaction occurs, the usual emergency medications will be administered. Doctors will closely monitor how the reaction develops. No additional tests or visits are required. The results of this study could help improve allergy treatment in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antihistamines plus oral steroids | Active comparator | Drug: Antihistamines, Drug: Systemic corticosteroids, Drug: Adrenaline (rescue medication)Participants receive oral antihistamines plus oral systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated. |
| Antihistamines only (no steroids) | Active comparator | Drug: Antihistamines, Drug: Adrenaline (rescue medication)Participants receive oral antihistamines without systemic corticosteroids for treatment of allergic reactions occurring during the oral food challenge. Intramuscular adrenaline may be administered as rescue medication if clinically indicated. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- suspected or confirmed IgE-mediated food allergy
Key exclusion criteria (4 listed)
- Non-IgE mediated food allergies
- Non-food allergies
- Age outside the specified range
- Contraindications for an oral food challenge or oral steroid use within one week before the challenge.
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 |
|---|---|---|
| AntihistaminesAlso: Dimetindene maleate, LevocetirizineOral administration of antihistamines for treatment of allergic symptoms during the oral food challenge. | Drug | Antihistamines only (no steroids), Antihistamines plus oral steroids |
| Systemic corticosteroidsAlso: Betamethasone, PrednisoloneOral administration of systemic corticosteroids as adjunctive treatment of allergic reactions during the oral food challenge. | Drug | Antihistamines plus oral steroids |
| Adrenaline (rescue medication)Also: AdrenalineIntramuscular administration of adrenaline as rescue treatment for severe allergic reactions (anaphylaxis), administered as clinically indicated. | Drug | Antihistamines only (no steroids), Antihistamines plus oral steroids |
Primary outcome
Time to complete resolution of allergic symptoms
Time frame: From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.
Time from onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, comparing treatment with antihistamines alone versus antihistamines plus oral steroids.
6 secondary outcomes
Total number of adrenaline doses and cumulative adrenaline dose
Time frame: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.
Total number of antihistamine doses and cumulative antihistamine dose
Time frame: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.
Severity of allergic reaction
Time frame: From onset of allergic reaction during the oral food challenge until resolution of symptoms or end of post-reaction observation period, assessed up to 24 hours.
Hospitalization and intensive care unit admission
Time frame: From onset of allergic reaction during the oral food challenge until hospital discharge or end of observation period, assessed up to 24 hours.
Time from onset of allergic symptoms to patient discharge
Time frame: From onset of allergic symptoms during the oral food challenge until patient discharge, assessed up to 24 hours.
Late-phase allergic reactions
Time frame: From resolution of initial allergic symptoms during the oral food challenge until 24 hours after onset of the allergic reaction.
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 27 Jan 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antihistamines, Systemic corticosteroids and Adrenaline (rescue medication) in people with Anaphylactic Reaction and Anaphylaxis, run by Johannes Trueck at 2 sites in Switzerland.
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 4 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Johannes Trück, PD Dr. med. DPhil (+41 44 249 49 49, johannes.trueck@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete resolution of allergic symptoms (time frame: From onset of allergic symptoms during the oral food challenge until complete resolution of all allergic symptoms, assessed up to 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.