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

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.

Study Overview

• Status: Completed
• Conditions: Poisoning by Scorpion Sting
• Intervention / Treatment: Biological: Equine F(ab')2 antivenom; Other: Intensive care support plus placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Morocco
  • Fès, Morocco
    • CHU Hassan II de Fès
  • Marrakech, Morocco
    • Hôpital Ibn Zohr, Marrakech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female 6 months to 15 years
• Class II B or III scorpion envenomation
• Presenting within 5 hours of sting
• Informed consent read and signed by parent or legal guardian

Exclusion Criteria:

• Unable to provide informed consent
• Prior use of antivenom for this envenomation
• Allergy to horse serum
• Pregnant or breast-feeding
• Patients with underlying condition mimicking symptoms of scorpion envenomation (congenital heart disease, chronic oxygen therapy, etcetera)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Equine F(ab')2 antivenom; Intensive care support and Equine F(ab')2 antivenom	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 Names: Alacramyn NA; Scorpion North Africa and Middle East Immune F(ab')2(Equine)
Placebo Comparator: Placebo; Intensive care support plus placebo	Other: Intensive care support plus placebo; Intensive care support as needed plus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation	Comparison between antivenom and placebo groups of the number of cases showing improvement in class of envenomation.	4 hours after study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation.	Decrease in plasma venom levels from baseline to one hour after study drug administration; Respiratory rate (breaths per minute); Heart rate (beats per minute); Dose of dobutamine (cumulative, per hour);Incidence of cardiac failure; Incidence of ventilatory failure; Incidence of neurological failure; Mortality	To 16 hours after treatment until discharge time and date

Collaborators and Investigators

• Sponsor: Instituto Bioclon S.A. de C.V.
• Collaborators: Centre Antipoison et de Pharmacovigilane du Maroc; Institut Pasteur du Maroc
• Investigators: Study Director: Walter García, MD, Instituto Bioclon; Study Chair: Rachida Soulaymani, Pr, Centre Antipoison et de Pharamacovigilance du Maroc; Principal Investigator: Sanae Achour, FES University Hospital; Study Chair: Asmae Khattabi, Ecole Nationale de Santé Publique

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 15, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Effectiveness; New Antivenom; North Africa and Middle East Scorpio Envenomation
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Bites and Stings; Poisoning; Scorpion Stings; Physiological Effects of Drugs; Immunologic Factors; Antivenins
• Other Study ID Numbers: XM-10/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No