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Compare Two Anti-Scorpion Venom Serum In Children

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:
NCT01415830
First received: August 8, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Scorpion Sting
 Biological: Anti-scorpion venom serum Birmex
Biological: Anti-scorpion venom serum Alacramyn
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: 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

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 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 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 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).

  Eligibility

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415830

Locations
Mexico
Hospital General Regional de León
León, Guanajuato, Mexico, 37320
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01415830     History of Changes
Other Study ID Numbers: BIRMEX-ECA-03-2011
Study First Received: August 8, 2011
Last Updated: February 5, 2013
Health Authority: Mexico:Federal Commission for Sanitary Risks Protection (COFEPRIS)

Keywords provided by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.:
Anti-Scorpion venom serum
venom
efficacy
safety
children

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

ClinicalTrials.gov processed this record on May 23, 2013