Scorpion Sting Clinical Trial
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
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).
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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00739440 -
Randomized Controlled Trial to Compare Two Anti-scorpion Serums
|
Phase 4 |