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

NCT01336660 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-12-13

No results posted yet for this study

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.

Conditions

  • Poisoning by Scorpion Sting

Interventions

BIOLOGICAL

Equine F(ab')2 antivenom

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

OTHER

Intensive care support plus placebo

Intensive care support as needed plus placebo

Sponsors & Collaborators

  • Centre Antipoison et de Pharmacovigilane du Maroc

    collaborator UNKNOWN

  • Institut Pasteur du Maroc

    collaborator UNKNOWN

  • Instituto Bioclon S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Walter Garcia, MD · Instituto Bioclon

  • Rachida Soulaymani, Pr · Centre Antipoison et de Pharamacovigilance du Maroc

  • Sanae Achour · FES University Hospital

  • Asmae Khattabi · Ecole Nationale de Santé Publique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-21
Primary Completion
2018-11-01
Completion
2018-11-15

Countries

  • Morocco

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336660 on ClinicalTrials.gov