Trial | NCT01336660  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    56
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.
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 Started
Jul 21
2018
Primary Completion
Nov 01
2018
Study Completion
Nov 15
2018
Last Update
Dec 13
2018

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)

Other Intensive care support plus placebo

Intensive care support as needed plus placebo

Equine F(ab')2 antivenom Experimental

Intensive care support and Equine F(ab')2 antivenom

Placebo Placebo Comparator

Intensive care support plus placebo

Criteria 

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)
No Results Posted