NCT01415830

Compare Two Anti-Scorpion Venom Serum In Children

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Scorpion Sting

Interventions

Type	Name	Description
BIOLOGICAL	Anti-scorpion venom serum Birmex	the dose may be required for the patient according to clinical manifestations and evolution
BIOLOGICAL	Anti-scorpion venom serum Alacramyn	The dose may be required fot the patient according to clinical manifestations and evolution

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-08-12
• Last updated: 2013-02-07

Locations

1 site across 1 country: Mexico