Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2011-08-31
2012-05-31
Brief Summary
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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).
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Anti-scorpion venom serum Birmex
Patients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex
Anti-scorpion venom serum Alacramyn
The dose may be required fot the patient according to clinical manifestations and evolution
Anti-scorpion venom serum Alacramyn
Patients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
Anti-scorpion venom serum Birmex
the dose may be required for the patient according to clinical manifestations and evolution
Interventions
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Anti-scorpion venom serum Birmex
the dose may be required for the patient according to clinical manifestations and evolution
Anti-scorpion venom serum Alacramyn
The dose may be required fot the patient according to clinical manifestations and evolution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
1 Year
15 Years
ALL
No
Sponsors
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Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
OTHER
Responsible Party
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Principal Investigators
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Ma. Eugenia Jimenez-Corona, PhD
Role: PRINCIPAL_INVESTIGATOR
Laboratorios de Biologicos y Reactivos de México SA de CV
Locations
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Hospital General Regional de León
León, Guanajuato, Mexico
Countries
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Other Identifiers
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BIRMEX-ECA-03-2011
Identifier Type: -
Identifier Source: org_study_id
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