Compare Two Anti-Scorpion Venom Serum In Children
The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency.
On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).
|Scorpion Sting||Biological: Anti-scorpion venom serum Birmex Biological: Anti-scorpion venom serum Alacramyn||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
|Official Title:||Randomized Controlled Trial To Evaluate Efficacy And Safety Of The Polyvalent Anti-scorpion Venom Serum Of Birmex Versus Other Commercial Venom Serum In Children Population|
- Resolution of signs and symptoms of scorpion envenomation [ Time Frame: after treatment (expected average of 12 hrs) ]
- Evaluate the adverse events in every treated child [ Time Frame: inmediately after treatment and until 5 days later ]
|Study Start Date:||August 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Anti-scorpion venom serum Birmex
Patients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex
Biological: Anti-scorpion venom serum Alacramyn
The dose may be required fot the patient according to clinical manifestations and evolution
Other Name: antiscorpion venom serum
Active Comparator: Anti-scorpion venom serum Alacramyn
Patients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
Biological: Anti-scorpion venom serum Birmex
the dose may be required for the patient according to clinical manifestations and evolution
Other Name: anti-scorpion venom serum
We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.
This is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum (Alacramyn).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415830
|Hospital General Regional de León|
|León, Guanajuato, Mexico, 37320|
|Principal Investigator:||Ma. Eugenia Jimenez-Corona, PhD||Laboratorios de Biologicos y Reactivos de México SA de CV|