Compare Two Anti-Scorpion Venom Serum In Children

February 5, 2013 updated by: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37320
        • Hospital General Regional de Leon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Scorpion sting
  2. Either sex
  3. Age 1 to 15 years
  4. Signing an informed consent (signed by parent or guardian)
  5. Being residents of the state of Guanajuato

Exclusion Criteria:

  1. Previous treatment with gamma globulin or immunoglobulin
  2. Blood transfusion at any stage of life
  3. Patients treated with drugs that interact with anti-scorpion serum
  4. History or history of sensitivity or intolerance to anti-scorpion serum or horse products
  5. Pregnancy
  6. Any immunodeficiency
  7. Patients who have participated in a research protocol in the previous month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-scorpion venom serum Birmex
Patients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex
Biological: Anti-scorpion venom serum Alacramyn
The dose may be required fot the patient according to clinical manifestations and evolution
Other Names:
  • antiscorpion venom serum
Active Comparator: Anti-scorpion venom serum Alacramyn
Patients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
Biological: Anti-scorpion venom serum Birmex
the dose may be required for the patient according to clinical manifestations and evolution
Other Names:
  • anti-scorpion venom serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resolution of signs and symptoms of scorpion envenomation
Time Frame: after treatment (expected average of 12 hrs)
after treatment (expected average of 12 hrs)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Ma. Eugenia Jimenez-Corona, PhD, Laboratorios de Biologicos y Reactivos de México SA de CV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimate)

August 12, 2011

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIRMEX-ECA-03-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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