CompletedPhase 2/3

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

Morocco56 participantsStarted 2018-07-21

Plain-language 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.

Who can participate

Age range6 Months – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

Trial details

NCT IDNCT01336660

SponsorInstituto Bioclon S.A. de C.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-01

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