Black Widow Spider Antivenin for Patients With Systemic Latrodectism

Summary

The purpose of this study is to test the efficacy and safety of a new antivenom called Analatro® for treating black widow spider bites in patients who present to a hospital emergency room within 24 hours of symptom onset. This study will be a phase III, multi-center, double-blind, randomized controlled study that takes place in emergency departments. The primary aim of this study is to determine the proportion of patients in which pain control was not achieved by 48 hours post treatment. Secondary aims are as follows: 1) a reduction in pain intensity at the end of the treatment phase compared to baseline; 2) the proportion of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related adverse events occurred; and 4) to determine if serious, drug-related adverse events in Analatro-treated patients occurred at a rate greater than one in 10 (10%).

Timeline

Start

2009-10

Primary completion

2014-10

Completion

2014-10

Outcome

Met primary endpoint

paper CONCLUSION: The F(ab')2 antivenom met the predefined primary outcome of reduced treatment failures. PMID 30926190 ↗

paper There were 15 treatment failures in the antivenom group and 24 in the placebo group (P=.019). PMID 30926190 ↗

Publications

• Dart RC, Bush SP, Heard K, Arnold TC, Sutter M, Campagne D, Holstege CP, Seifert SA, Lo JCY, Quan D, Borron S, Meurer DA, Burnham RI, McNally J, Garcia-Ubbelohde W, Anderson VE. The Efficacy of Antivenin Latrodectus (Black Widow) Equine Immune F(ab')2 Versus Placebo in the Treatment of Latrodectism: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial. Ann Emerg Med. 2019 Sep;74(3):439-449. doi: 10.1016/j.annemergmed.2019.02.007. Epub 2019 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Analatro	Protein / enzyme biologic	30 ml	Intravenous

Indications