Randomized Controlled Trial to Compare Two Anti-scorpion Serums

Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.120 enrolled

Overview

The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial 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 15 and 60 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Scorpion Sting

Interventions

serum antiscorpionBIOLOGICAL

The dose may be required for the patient according to clinical manifestations and evolution

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sting scorpion * Informed consent * Age 15-60 * Either sex * Resident in study area Exclusion Criteria: * Previous treatment with gammaglobulin * Blood transfusion at any stage of life * Sensitivity or intolerance to serums antiscorpion or horse products * Pregnancy * Some immunodeficiency

Outcomes

Primary Outcomes

Resolution of signs and symptoms of scorpion envenomation

Time frame: after treatment (expected average of 12 hrs)

Secondary Outcomes

Evaluate the adverse events in every treated child

Time frame: inmediately after treatment and until 5 days later

Data from ClinicalTrials.gov

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