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Redback Spider Antivenom Evaluation II Study (RAVE II Study)

Randomised controlled trial of intravenous antivenom versus placebo in the treatment of pain and systemic effects in redback spider bite

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000063213
Acronym
RAVE-II
Enrollment
240
Registered
2009-01-23
Start date
2009-01-24
Completion date
2013-06-21
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Redback spider bites are common in Australia and red back spider envenoming (latrodectism) is the commonest significant envenoming in Australia. Redback spider antivenom (RBS AV) is the most frequently used antivenom in Australia. An estimated 5000 redback spider bites are treated with antivenom each year requiring a median of 2 vials of redback spider antivenom and an emergency department or hospital admission. We estimate this costs between $200,000 and $500,000 annually for antivenom and an equivalent amount in hospital costs. Early adverse reactions occur in approximately 4% of cases (40 to 120 patients annually) causing additional risk to the patient and costs to the health care system. Redback antivenom treatment therefore carries a considerable cost and measureable risk. However, despite the wide use of RBS AV and the clinical impression that it is effective, it has never been tested in a placebo randomized controlled trial. The results from our recent randomised controlled trial of intravenous versus intramuscular administration of redback spider antivenom (RAVE I) raise questions about the effectiveness of the antivenom. It is therefore essential to determine whether RBS AV is effective and justifies the costs and risks associated with its use. We propose to determine the effectiveness of RBS AV in a multicentre randomised placebo-controlled trial.

Interventions

Two vials (500U/vial) of redback spider antivenom (CSL Ltd) given as a single dose intravenously diluted in 200 mL of normal saline over 20 minutes.

Sponsors

Calvary Mater Newcastle
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
7 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1.A definite or likely redback spider bite according to either of the following criteria: a.The spider causing the bite was clearly identified by the patient or clinician, OR b.A clinical syndrome consistent with typical redback spider envenoming, that is the sensation of a bite followed by two or more of: 1. increasing pain over the first hour 2. radiating, regional or generalised pain 3. local or regional diaphoresis AND 2.The treating clinician would normally treat the patient with antivenom, namely either for: 1. moderate envenoming = moderate to severe local pain without systemic envenoming, or; 2. severe envenoming = moderate to severe local pain and systemic features

Exclusion criteria

1.Patients who have received antivenom for this envenoming prior to enrolment 2.Children aged <8 years because of unreliability of the Verbal Numerical Rating Scale for assessment of pain in this group 3.Presentation to hospital >36 hours after the bite

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026