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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by Instituto Bioclon S.A. de C.V.
Sponsor:
Collaborators:
Centre Antipoison et de Pharmacovigilane du Maroc
Institut Pasteur du Maroc
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01336660
First received: April 14, 2011
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Poisoning by Scorpion Sting
Biological: Equine F(ab')2 antivenom
Other: Intensive care support plus placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official 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

Further study details as provided by Instituto Bioclon S.A. de C.V.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 60
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Equine F(ab')2 antivenom
Intensive care support and Equine F(ab')2 antivenom
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 Names:
  • Alacramyn NA
  • Scorpion North Africa and Middle East Immune F(ab')2(Equine)
Placebo Comparator: Placebo
Intensive care support plus placebo
Other: Intensive care support plus placebo
Intensive care support as needed plus placebo

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.

  Eligibility

Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336660

Contacts
Contact: Walter Garcia, MD 0052 (1) 55 3733 3630 wgarcia@silanes.com.mx
Contact: Rachida Soulaymani, MD 00212537777169 rsoulaymani@gmail.com

Locations
Morocco
CHU Hassan II de Fès Not yet recruiting
Fès, Morocco
Contact: Harrandou Mustapha, MD       harandoumustapha@yahoo.fr   
Contact: Sanae Achour, Pr    2120661421282    achour_sanae@yahoo.fr   
Principal Investigator: Harrandou Mustapha, MD         
Hôpital Ibn Zohr, Marrakech Not yet recruiting
Marrakech, Morocco
Contact: Zakar Abdelkader, MD    212661490544    abdele_zakar@hotmail.fr   
Principal Investigator: Zakar Abdelkader, MD         
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
Centre Antipoison et de Pharmacovigilane du Maroc
Institut Pasteur du Maroc
Investigators
Study Director: Walter Garcia, MD Instituto Bioclon
Study Chair: Rachida Soulaymani, Pr Centre Antipoison et de Pharamacovigilance du Maroc
Principal Investigator: Sanae Achour FES University Hospital
Study Chair: Asmae Khattabi Ecole Nationale de Santé Publique
  More Information

Responsible Party: Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01336660     History of Changes
Other Study ID Numbers: XM-10/02
Study First Received: April 14, 2011
Last Updated: March 9, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: not yet decided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto Bioclon S.A. de C.V.:
Effectiveness
New Antivenom
North Africa and Middle East Scorpio Envenomation

Additional relevant MeSH terms:
Poisoning
Scorpion Stings
Chemically-Induced Disorders
Bites and Stings
Wounds and Injuries
Antivenins
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 24, 2017