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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.
Verified May 2012 by Instituto Bioclon S.A. de C.V.
Sponsor:
Collaborators:
Centre Antipoison et de Pharmacovigilane du Maroc
University of Arizona
Institut Pasteur du Maroc
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01336660
First received: April 14, 2011
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  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: Standard of care plus placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Poisoning
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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: 30
Study Start Date: July 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active treatment
Standard of care and active antivenom
 Biological: equine F(ab')2 antivenom

Calculation of the expected dose of Study Drug for effective treatment of envenomation by the species tested, assuming maximal venom injection and treatment of children within 5 hours of sting, projects a range of effective dose between 1 and 4 vials administered intravenously. Because it is not currently possible to judge, on an individual clinical basis, which patients have received the largest doses of scorpion venom, this protocol uses a single dose of 4 vials, intravenous, as the most likely dose to ensure efficacy in the largest number of subjects.

Lyophilized placebo consisting of inactive excipient materials, and its packaging will be indistinguishable from the active drug.

Other Names:
  • Alacramyn NAMO
  • Scorpion North Africa and Middle East Immune F(ab')2(Equine)
Placebo Comparator: Placebo control
Standard of care plus placebo
 Other: Standard of care 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336660

Contacts
Contact: Rachida Soulaymani, MD 00212537777169 rsoulaymani@gmail.com
Contact: Asmae Khattabi, MD 00212537777167 asmaekhattabi@yahoo.fr

Locations
Morocco
Hôpital Essalama, El Kalaa des Sraghnas Not yet recruiting
El Kalaa, Morocco
Contact: Taibi Bouchaib, MD     21261368814     chaib2007@hotmail.com    
Principal Investigator: Taibi Bouchaib, MD            
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
University of Arizona
Institut Pasteur du Maroc
Universidad Nacional Autonoma de Mexico
Investigators
Study Director: Walter Garcia, MD Instituto Bioclon
Principal Investigator: Rachida Soulaymani, Pr Centre Antipoison et de Pharamacovigilance du Maroc
Study Chair: Leslie Boyer, MD VIPER Institute, University of Arizona
  More Information

No publications provided

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: May 14, 2012
Health Authority: Morocco: Ministry of Public Health

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
Bites and Stings
Substance-Related Disorders
Wounds and Injuries
 Antivenins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013