COrticosteroids for Biphasic Reactions in Anaphylaxis - COBRA

Randomised control trial comparing incidence of biphasic anaphylaxis reactions, in patients who were successfully treated acute anaphylaxis, given oral Prednisone/Prednisolone at discharge compared to no corticosteroid therapy

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001339549

Acronym

COBRA

Enrollment

250

Registered

2024-11-05

Start date

2025-01-06

Completion date

2026-08-04

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There is significant debate amongst clinicians on whether corticosteroids should be prescribed for patients who have presented with anaphylaxis. On one hand you have an unknown amount of risk of a biphasic reaction, which can be as severe as the initial reaction, and the known side effect profile of corticosteroids on the other. An appropriately powered, prospective randomised control trial, RCT, may help clinicians with this clinical decision and assist in both national and international guidelines on anaphylaxis treatment.

Interventions

Patients who are randomised to the treatment arm will be given a 2mg/kg dose of oral corticosteroid, Prednisone if they can swallow tablets or Prednisolone suspension if they cannot, prior to discharge and a prescription for two days of the same steroid and dose to take at home. All patients will also receive an adrenaline auto-injector device '(Epi-pen)' and a script for oral antihistamine, Cetirizine - dosing as per New Zealand Formulary for age, to take as required.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

Successfully treated acute anaphylaxis deemed safe for hospital discharge by the senior medical doctor overseeing the patients care. A senior medical doctor will be defined as the doctor who would normally oversee a patients care and discharge during that shift. This will usually be the Senior Medical Officer (SMO), but maybe be a Senior Registrar, Medical Officer Special Scale (MOSS) or Fellow, especially during night shifts. Anaphylaxis will be defined using the NIAID/FAAN criteria

Exclusion criteria

Weight under 15 kg Received corticosteroids during treatment of initial reaction Allergy to Prednisone/Prednisolone - these patients can be put in non-treatment arm without randomisation Unable to be followed up by research team Unable to represent or seek urgent medical care due to geographic, communication or transport restraints

Outcome results