Randomized Controlled Trial to Compare Two Anti-scorpion Serums

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

Completed

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Key information

Conditions

Scorpion Sting Bites and Stings Chemically-Induced Disorders Poisoning Scorpion Stings Wounds and Injuries

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

serum antiscorpion

Biological

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

Other names: anti-Scorpion venom Serum

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Aug 21, 2008
Registry last updated: Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed