Clinical trial NCT01336660: A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Poisoning by Scorpion Sting
Keywords: Effectiveness
New Antivenom
North Africa and Middle East Scorpio Envenomation
Lead sponsor: Instituto Bioclon S.A. de C.V.
Sponsor class: INDUSTRY
Collaborators: name: Centre Antipoison et de Pharmacovigilane du Maroc
name: Institut Pasteur du Maroc
First posted: 2011-04-18
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)

Primary outcomes:
measure: To demonstrate the effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation
timeFrame: 4 hours after study drug
Secondary outcomes:
measure: Effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation.
timeFrame: To 16 hours after treatment until discharge time and date
Other outcomes:
Locations:
city: Fès
country: Morocco
facility: CHU Hassan II de Fès
city: Marrakech
country: Morocco
facility: Hôpital Ibn Zohr, Marrakech
Study officials:
affiliation: Instituto Bioclon
name: Walter Garcia, MD
role: STUDY_DIRECTOR
affiliation: Centre Antipoison et de Pharamacovigilance du Maroc
name: Rachida Soulaymani, Pr
role: STUDY_CHAIR
affiliation: FES University Hospital
name: Sanae Achour
role: PRINCIPAL_INVESTIGATOR
affiliation: Ecole Nationale de Santé Publique
name: Asmae Khattabi
role: STUDY_CHAIR
References: