A Trial of Equine F (ab')2 Antivenom for Treatment of Scorpion Envenomation in Morocco
|Poisoning by Scorpion Sting||Biological: Equine F(ab')2 antivenom Other: Intensive care support plus placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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|
- 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.
- 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
|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)|
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
Placebo Comparator: Placebo
Intensive care support plus placebo
Other: Intensive care support plus placebo
Intensive care support as needed plus placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336660
|Contact: Walter Garcia, MD||0052 (1) 55 3733 email@example.com|
|Contact: Rachida Soulaymani, MDfirstname.lastname@example.org|
|CHU Hassan II de Fès||Not yet recruiting|
|Contact: Harrandou Mustapha, MD email@example.com|
|Contact: Sanae Achour, Pr 2120661421282 firstname.lastname@example.org|
|Principal Investigator: Harrandou Mustapha, MD|
|Hôpital Ibn Zohr, Marrakech||Not yet recruiting|
|Contact: Zakar Abdelkader, MD 212661490544 email@example.com|
|Principal Investigator: Zakar Abdelkader, MD|
|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|