Clinical Trial: Compare Two Anti-Scorpion Venom Serum In Children

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

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

Brief 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 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 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).

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: Same as current

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

Original Secondary Outcome: Same as current

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

Dates:
Date Received: August 8, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 5, 2013
Last Verified: February 2013