Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
|Scorpion Sting Envenomation||Biological: Antivenin Centruroides (scorpion) equine immune F(ab')2||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation|
- Resolution of clinically important systemic signs of scorpion envenomation within four hours after Alacramyn administration. [ Time Frame: Assessments conducted at 1, 2 and 4 hours post administration ]
- Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment. [ Time Frame: One hour ]
|Study Start Date:||May 2005|
|Study Completion Date:||August 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Biological: Antivenin Centruroides (scorpion) equine immune F(ab')2
3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
The purpose of this open label, confirmatory, controlled clinical trial in Mexico was to provide additional data safety and efficacy of Alacramyn® for treatment of patients envenomed by scorpion sting.
This study took place at Morelos Children's Hospital in Cuernavaca, Mexico.
Patients who arrived at the emergency department presenting with scorpion sting symptoms were evaluated for treatment with respect to the inclusion/exclusion criteria according to the study procedures. Only patients with clinically important systemic signs of scorpion sting envenomation were included in the study. Baseline measures included severity evaluation of the scorpion sting envenomation. The patient's vital signs, concomitant medication, medical history and demographic data were collected. Blood tests were done for haematology, chemistry, venom and anti-venom levels and urine test.
After informed consent and inclusion/exclusion criteria were obtained and verified, and the baseline measurements completed, three vials of Alacramyn® were administered. At the one hour assessment an additional vial of Alacramyn® was administered if important systemic signs of scorpion envenomation were present. The assessment was repeated at two hours and a final vial of Alacramyn® was administered if deemed necessary. Patient were discharged after the 4 hour assessment if symptoms were resolved. Prior to discharge repeat lab work, physical assessments, and vital signs were done. Those remaining for extended care underwent final study assessments at time of hospital discharge or at 24 hours after study drug infusion if hospitalization continued.
All patients who participated in the study were contacted 7 and 14 days after treatment, looking for symptoms suggestive of ongoing venom effect, delayed serum sickness, as well as for any other adverse event reported by the patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599923
|Children's Hospital of Morelos|
|Cuernavaca, Morelos, Mexico|
|Study Director:||Walter Garcia Ubbelohde, MD||Instituto Bioclon|
|Principal Investigator:||Leslie V. Boyer, MD||VIPER Institute, University of Arizona|
|Principal Investigator:||Neydi Osnaya, MD||Children's Hospital of Morelos|
|Study Chair:||Alejandro Alagon, PhD||Universidad Nacional Autonoma de Mexico|