RecruitingACTRN12606000333516

Ant Venom Immunotherapy: Improving method and maintenance.

A randomised 2x2 comparison of ultra-rush with semi-rush initiation, and 50 microgram versus 100 microgram maintenance venom immunotherapy for preventing anaphylaxis in jack jumper ant venom allergic people.


Sponsor

Department of Health and Human Services, Tasmanian Government

Enrollment

800 participants

Start Date

Sep 4, 2006

Study Type

Interventional

Conditions

Summary

The objectives of this study are to improve the delivery of venom immunotherapy (VIT) by assessing the efficacy and safety of different approaches to venom immunotherapy, namely ultra-rush (ultra-rapid initiation over 2 days) versus semi-rush (initiation over 10 weeks) and half-dose (50 microgram) versus standard dose (100 microgram) maintenance treatment. Specific hypotheses are that: (i) ultra-rush initiation will be equivalent to outpatient semi-rush initiation in terms of allergic reaction rates to immunotherapy; (ii) A maintenance dose of 50 mcg will be as efficacious as a 100 mcg maintenance dose, and; (iii) VIT with both initiation methods and maintenance doses will have a sustained positive impact (reduced reaction risk) after cessation of VIT. The study will have important implications. If the different approaches are equivalent, we will be able to significantly reduce the amount of venom extract used and thus increase the number of patients that we can treat, given that our venom supplies are expensive and limited. Because it will be impossible to conceal treatment allocations, the different initiation methods will be unblinded. Maintenance doses will be single blinded (known to the treating doctor but not the patient) because of the significant day-to-day dose adjustments required during immunotherapy would make double-blinding difficult and potentially dangerous. The main outcome measures will be (1) the occurence of systemic allergic reactions to immunotherapy (safety of treatment) and (2) systemic allergic reactions to deliberate sting challenges and accidental stings (effectiveness of treatment)


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is testing the best way to give venom immunotherapy (allergy shots) to people who have had serious allergic reactions to jack jumper ant stings. Jack jumper ants are native to Australia and their stings can cause life-threatening reactions in some people. Venom immunotherapy involves gradually giving small amounts of ant venom to make the body less reactive to it over time. The study is comparing two ways to start this treatment (quick over 2 days vs. slower over 10 weeks) and two different ongoing dose levels (low vs. standard), to find the safest and most effective approach. You may be eligible if: - You are a child or adult - You have had one or more serious (systemic) allergic reactions to a known or suspected jack jumper ant sting You may NOT be eligible if: - Your allergy test (skin test and blood test) came back negative for venom-specific antibodies - You are pregnant at the time treatment begins - You have a psychiatric illness that would prevent you from understanding the study - You have severe heart or lung disease that puts you at high risk from minor allergic reactions Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Venom immunotherapy by subcutaneous injection; randomised 2 x 2 factorial design; ultra-rush (treatment initiation over 2 days) versus semi-rush (treatment initiation over 10 weeks), and 50 mcg versus

Venom immunotherapy by subcutaneous injection; randomised 2 x 2 factorial design; ultra-rush (treatment initiation over 2 days) versus semi-rush (treatment initiation over 10 weeks), and 50 mcg versus 100 mcg maintenance dosing every three months for 3-5 years. A patient's choice arm is also available for part of the study where the patient may select either or both of initiation method and maintenance dose.


Locations(1)

Australia

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ACTRN12606000333516