Randomized Controlled Trial to Compare Two Anti-scorpion Serums

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00739440
First received: August 19, 2008
Last updated: August 6, 2013
Last verified: August 2013
  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
Scorpion Sting
Biological: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Resolution of signs and symptoms of scorpion envenomation [ Time Frame: after treatment (expected average of 12 hrs) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the adverse events in every treated child [ Time Frame: inmediately after treatment and until 5 days later ] [ Designated as safety issue: Yes ]

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 with scorpion sting, will receive serum antiscorpion elaborated by Birmex
Biological: serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution
Other Name: anti-Scorpion venom Serum
Experimental: II
Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
Biological: serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution
Other Name: anti-Scorpion venom 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00739440     History of Changes
Other Study ID Numbers: Birmex-01-2008
Study First Received: August 19, 2008
Last Updated: August 6, 2013
Health Authority: Mexico: Ministry of Health

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

ClinicalTrials.gov processed this record on July 20, 2014