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Completed

NCT Number: NCT01336660

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

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.

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Key information

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

CHU Hassan II de Fès, Fes, Morocco

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Equine F(ab')2 antivenom

Biological

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)

Intensive care support plus placebo

Other

Intensive care support as needed plus placebo

Primary outcomes

  1. To demonstrate the effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation

    Time frame: 4 hours after study drug

    Comparison between antivenom and placebo groups of the number of cases showing improvement in class of envenomation.

Secondary outcomes

  1. Effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation.

    Time frame: To 16 hours after treatment until discharge time and date

    Decrease 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

Sponsors and collaborators

Lead sponsor

Instituto Bioclon S.A. de C.V.

Industry

Collaborators

  • Centre Antipoison et de Pharmacovigilane du Maroc
  • Institut Pasteur du Maroc

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2011
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.