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

NCT ID: NCT01336660

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-21

Study Completion Date

2018-11-15

Brief Summary

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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

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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.

Conditions

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Poisoning by Scorpion Sting

Keywords

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Effectiveness New Antivenom North Africa and Middle East Scorpio Envenomation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Equine F(ab')2 antivenom

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

Group Type EXPERIMENTAL

Equine F(ab')2 antivenom

Intervention Type BIOLOGICAL

A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute

Placebo

Intensive care support plus placebo

Group Type PLACEBO_COMPARATOR

Intensive care support plus placebo

Intervention Type OTHER

Intensive care support as needed plus placebo

Interventions

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Equine F(ab')2 antivenom

A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute

Intervention Type BIOLOGICAL

Intensive care support plus placebo

Intensive care support as needed plus placebo

Intervention Type OTHER

Other Intervention Names

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Alacramyn NA Scorpion North Africa and Middle East Immune F(ab')2(Equine)

Eligibility Criteria

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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)
Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Antipoison et de Pharmacovigilane du Maroc

UNKNOWN

Sponsor Role collaborator

Institut Pasteur du Maroc

UNKNOWN

Sponsor Role collaborator

Instituto Bioclon S.A. de C.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walter Garcia, MD

Role: STUDY_DIRECTOR

Instituto Bioclon

Rachida Soulaymani, Pr

Role: STUDY_CHAIR

Centre Antipoison et de Pharamacovigilance du Maroc

Sanae Achour

Role: PRINCIPAL_INVESTIGATOR

FES University Hospital

Asmae Khattabi

Role: STUDY_CHAIR

Ecole Nationale de Santé Publique

Locations

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CHU Hassan II de Fès

Fes, , Morocco

Site Status

Hôpital Ibn Zohr, Marrakech

Marrakesh, , Morocco

Site Status

Countries

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Morocco

Other Identifiers

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XM-10/02

Identifier Type: -

Identifier Source: org_study_id