Clinical Trial: Randomized Controlled Trial to Compare Two Anti-scorpion Serums

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum

Brief Summary: 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

Detailed Summary:

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.

Sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

Current Primary Outcome: Resolution of signs and symptoms of scorpion envenomation [ Time Frame: after treatment (expected average of 12 hrs) ]

Original Primary Outcome: Measuring of IgG, IgM, IgE [ Time Frame: baseline and 12 hrs ]

Current Secondary Outcome: Evaluate the adverse events in every treated child [ Time Frame: inmediately after treatment and until 5 days later ]

Original Secondary Outcome: Security of treatment [ Time Frame: baseline and 12 hrs ]

Information By: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

Dates:
Date Received: August 19, 2008
Date Started: August 2008
Date Completion:
Last Updated: August 6, 2013
Last Verified: August 2013