The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

Latrodectism Clinical Trial

Official title:

The Efficacy and Safety of Aracmyn® [Antivenin Latrodectus (Black Widow)Equine Immune F(ab)2], in Patients With Systemic Latrodectism: A Phase II, Multi-Center, Randomized, Double-Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00247078
• Other study ID #: AR-03/02
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2005
• Last updated: June 11, 2008
• Start date: October 2005
• Est. completion date: December 2006

Study information

• Verified date: June 2008
• Source: Instituto Bioclon S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness of an investigational antivenom and the current standard of care (pain management with opioid analgesics) for treating patients with a widow spider bite. The working hypotheses are as follows:

1. the investigational antivenom is more promptly effective at alleviating the pain associated with a widow spider bite than routine management with opioid pain medication

2. the investigational antivenom is as safe a treatment as opioid pain medication in treating patients with a widow spider bite.

Description:

The purpose of this randomized, double-blind, multi-center phase II trial is to examine the safety and efficacy of Aracmyn® [Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2], a new antivenom, for treatment of patients envenomed by the widow spider. Twenty-four subjects will be randomized to receive either the study drug or control (normal saline) through intravenous (IV) infusion. Following infusion, subjects will be monitored for changes in pain and clinical signs during a two-hour observation period. A standard dose of IV fentanyl will be offered to all subjects as pain medication at specific intervals following treatment. Vital signs, blood samples, and pain intensity scores (using a visual analog scale, VAS) will be collected before and after the infusion, as well as during the observation period. This study uses a treatment failure protocol, which involves administration of Merck Antivenin to subjects who do not obtain adequate pain relief from the study drug or control. Primary efficacy and safety endpoints for this 12-month trial will be improvement in pain intensity and clinical signs and incidence of adverse events, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• patient presents for treatment within 72 hours from time of symptoms onset

• clinical diagnosis of widow spider envenomation

• patient has moderate to severe pain intensity

Exclusion Criteria:

• history of significant cardiac, respiratory, hepatic, or renal disease

• distracting injury or chronic pain syndrome that would obscure pain intensity assessment

• history of asthma or known sensitivity to fentanyl, morphine, diazepam, or equine serum

• pregnant or lactating

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arachnidism
• Latrodectism

Intervention

Biological:
• widow spider antivenom
3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans
• Placebo

Locations

Country	Name	City	State
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bioclon S.A. de C.V.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	between-treatment groups difference in pain intensity (pre- and post-treatment)		within first two hours	No
Secondary	between-treatment groups difference in proportion of treatment failures (absence of pain relief or return to hospital)		within 24 hours after discharge from emergency department	No
Secondary	between-treatment groups difference in incidence of drug-related adverse events.		onset of adverse events within 21 days	Yes