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Randomized Controlled Trial to Compare Two Anti-Scorpion Serums

This study has been completed.
Sponsor:
Information provided by:
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00739440
First received: August 19, 2008
Last updated: November 14, 2008
Last verified: November 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Insect Bites
 Drug: serum antiscorpion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum

Further study details as provided by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.:

Primary Outcome Measures:
  • Measuring of IgG, IgM, IgE [ Time Frame: baseline and 12 hrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Security of treatment [ Time Frame: baseline and 12 hrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Patients 15 to 60 years, will receive serum elaborated by Birmex
 Drug: serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution
Other Name: serum antiscorpion
Experimental: II
Patients 15 to 60 years, will receive other commercial serum (Alacramyn)
 Drug: serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution
Other Name: serum antiscorpion

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 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.

We evaluate the production of IgG, IgM and IgE through ELISA in baseline measurement and at 12 pm. It will evaluate the levels of IgG, IgM and IgE comparing the treatment groups.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739440

Sponsors and Collaborators
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Investigators
Principal Investigator: Jimenez C Ma. Eugenia, PhD Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
  More Information

No publications provided

Responsible Party: Ma. Eugenia Jiménez Corona, BIRMEX
ClinicalTrials.gov Identifier: NCT00739440     History of Changes
Other Study ID Numbers: Birmex-01-2008
Study First Received: August 19, 2008
Last Updated: November 14, 2008
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Insect Bites and Stings
Bites and Stings
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on June 18, 2013