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

Instituto Bioclon

Status and phase

Completed

Phase 3

Phase 2

Conditions

Poisoning by Scorpion Sting

Treatments

Biological: Equine F(ab')2 antivenom

Other: Intensive care support plus placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01336660

XM-10/02

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

6 months to 15 years old

Volunteers

No Healthy Volunteers

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)