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

NCT01336660 | Completed Phase 2 DMC

• 1 other identifier: XM-10/02
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Poisoning by Scorpion Sting

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  4 hours after study drug

Secondary Outcomes (1)

• 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 date

Study Arms (2)

Equine F(ab')2 antivenom

EXPERIMENTAL

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

Biological: Equine F(ab')2 antivenom

Placebo

PLACEBO COMPARATOR

Intensive care support plus placebo

Other: Intensive care support plus placebo

Interventions

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

Also known as: Alacramyn NA, Scorpion North Africa and Middle East Immune F(ab')2(Equine)

Equine F(ab')2 antivenom

Intensive care support plus placebo OTHER

Intensive care support as needed plus placebo

Placebo

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Bioclon S.A. de C.V.: lead
• Centre Antipoison et de Pharmacovigilane du Maroc: collaborator
• Institut Pasteur du Maroc: collaborator

Study Sites (2)

CHU Hassan II de Fès

Fes, Morocco

Location

Hôpital Ibn Zohr, Marrakech

Marrakesh, Morocco

Location

Study Officials

• Walter Garcia, MD

  Instituto Bioclon

  STUDY DIRECTOR

• Rachida Soulaymani, Pr

  Centre Antipoison et de Pharamacovigilance du Maroc

  STUDY CHAIR

• Sanae Achour

  FES University Hospital

  PRINCIPAL INVESTIGATOR

• Asmae Khattabi

  Ecole Nationale de Santé Publique

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 18, 2011
• Study Start: July 21, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 15, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

MO (2)