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

Poisoning by Scorpion Sting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336660
• Other study ID #: XM-10/02
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 21, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: December 2018
• Source: Instituto Bioclon S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 15, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Poisoning
• Poisoning by Scorpion Sting
• Scorpion Stings

Intervention

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

Locations

Country	Name	City	State
Morocco	CHU Hassan II de Fès	Fès
Morocco	Hôpital Ibn Zohr, Marrakech	Marrakech

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Bioclon S.A. de C.V.	Centre Antipoison et de Pharmacovigilane du Maroc, Institut Pasteur du Maroc

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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