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Randomized Controlled Trial to Compare Two Anti-scorpion Serums

Primary Purpose

Scorpion Sting

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
serum antiscorpion
Sponsored by
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scorpion Sting

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    I

    II

    Arm Description

    Patients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex

    Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)

    Outcomes

    Primary Outcome Measures

    Resolution of signs and symptoms of scorpion envenomation

    Secondary Outcome Measures

    Evaluate the adverse events in every treated child

    Full Information

    First Posted
    August 19, 2008
    Last Updated
    August 6, 2013
    Sponsor
    Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00739440
    Brief Title
    Randomized Controlled Trial to Compare Two Anti-scorpion Serums
    Official Title
    Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scorpion Sting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I
    Arm Type
    Experimental
    Arm Description
    Patients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex
    Arm Title
    II
    Arm Type
    Experimental
    Arm Description
    Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
    Intervention Type
    Biological
    Intervention Name(s)
    serum antiscorpion
    Other Intervention Name(s)
    anti-Scorpion venom Serum
    Intervention Description
    The dose may be required for the patient according to clinical manifestations and evolution
    Primary Outcome Measure Information:
    Title
    Resolution of signs and symptoms of scorpion envenomation
    Time Frame
    after treatment (expected average of 12 hrs)
    Secondary Outcome Measure Information:
    Title
    Evaluate the adverse events in every treated child
    Time Frame
    inmediately after treatment and until 5 days later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jimenez C Ma. Eugenia, PhD
    Organizational Affiliation
    Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Randomized Controlled Trial to Compare Two Anti-scorpion Serums

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