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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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01336660
Enrollment
56
Registered
2011-04-18
Start date
2018-07-21
Completion date
2018-11-15
Last updated
2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poisoning by Scorpion Sting

Keywords

Effectiveness, New Antivenom, North Africa and Middle East Scorpio Envenomation

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.

Interventions

BIOLOGICALEquine F(ab')2 antivenom

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

OTHERIntensive care support plus placebo

Intensive care support as needed plus placebo

Sponsors

Centre Antipoison et de Pharmacovigilane du Maroc
CollaboratorUNKNOWN
Institut Pasteur du Maroc
CollaboratorUNKNOWN
Instituto Bioclon S.A. de C.V.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 15 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
To demonstrate the effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation4 hours after study drugComparison between antivenom and placebo groups of the number of cases showing improvement in class of envenomation.

Secondary

MeasureTime frameDescription
Effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation.To 16 hours after treatment until discharge time and dateDecrease 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

Countries

Morocco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026