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| Name | Class |
|---|---|
| Centre Antipoison et de Pharmacovigilane du Maroc | UNKNOWN |
| Institut Pasteur du Maroc | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Equine F(ab')2 antivenom | Experimental | Intensive care support and Equine F(ab')2 antivenom |
|
| Placebo | Placebo Comparator | Intensive care support plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Alacramyn NAMO in the treatment of scorpion envenomation by reducing the severity of envenomation. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Hassan II de Fès | Fes | Morocco | ||||
| Hôpital Ibn Zohr, Marrakech |
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| Intensive care support plus placebo | Other | Intensive care support as needed plus placebo |
|
| To 16 hours after treatment until discharge time and date |
| Marrakesh |
| Morocco |