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

August 8, 2011
February 5, 2013
August 2011
May 2012   (final data collection date for primary outcome measure)
Resolution of signs and symptoms of scorpion envenomation [ Time Frame: after treatment (expected average of 12 hrs) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01415830 on ClinicalTrials.gov Archive Site
Evaluate the adverse events in every treated child [ Time Frame: inmediately after treatment and until 5 days later ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Compare Two Anti-Scorpion Venom Serum In Children
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).

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Scorpion Sting
  • 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
  • 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
  • Experimental: Anti-scorpion venom serum Birmex
    Patients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex
    Intervention: Biological: Anti-scorpion venom serum Alacramyn
  • Active Comparator: Anti-scorpion venom serum Alacramyn
    Patients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
    Intervention: Biological: Anti-scorpion venom serum Birmex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
1 Year to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01415830
BIRMEX-ECA-03-2011
Yes
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Not Provided
Principal Investigator: Ma. Eugenia Jimenez-Corona, PhD Laboratorios de Biologicos y Reactivos de México SA de CV
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP