NCT01336660

A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco

Phase 2/3 Study for Scorpion North Africa Middle East Envenomation With a Immune F(ab')2 (Equine) Antivenom Alacramyn NAMO. A Randomized, Double-Blind, Placebo-controlled, Prospective and Multicenter Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Instituto Bioclon S.A. de C.V. · Industry
• Sex: All
• Age: 6 Months – 15 Years
• Healthy volunteers: Not accepted

Summary

This study has the objective to demonstrate the effectiveness of Alacramyn NAMO in the treatment of North Africa and Middle East scorpions envenomation by reducing the severity of envenomation. The primary endpoint is make a comparison between antivenom and placebo groups, at 4 hours after study drug, of the number of cases showing improvement in class of envenomation.

Detailed description

In an effort to shorten hospital stay and to further decrease mortality, a new antivenom has been developed. This antivenom is a third generation F(ab')2 "fabotherapeutic" agent.It is administered intravenously which should lead to rapid neutralization of circulating venom. This study will demonstrate whether or not use of the new antivenom in children receiving standardized supportive care leads to resolution of the syndrome within 4 hours of treatment.The onset of clinical symptoms following a scorpion envenomation is usually within 5 to 30 minutes following the sting. Established a classification of the patient status to differentiate a simple scorpion sting from a severe envenomation. A simple sting (class I) is characterized by signs that are local only: pain at the inoculation point, redness, edema, and numbness. A class II envenomation is characterized by the presence of some systemic signs: hypothermia, hyperthermia, chills, nausea, abdominal pain and diarrhea. Being 15 years old or younger or the presence of priapism, vomiting, sweating, or a body temperature greater than 39°C are factors predictive of severity. A severe envenomation (class III) is characterized by cardiovascular failure, often leading to death; respiratory failure related to the cardiac failure; and neurologic failure due to hypoxia.

Conditions

• Poisoning by Scorpion Sting

Interventions

Type	Name	Description
BIOLOGICAL	Equine F(ab')2 antivenom	A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute
OTHER	Intensive care support plus placebo	Intensive care support as needed plus placebo

Timeline

• Start date: 2018-07-21
• Primary completion: 2018-11-01
• Completion: 2018-11-15
• First posted: 2011-04-18
• Last updated: 2018-12-13

Locations

2 sites across 1 country: Morocco