NCT00739440CompletedPhase 4
Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.0 sites120 target enrollmentStarted: August 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Resolution of signs and symptoms of scorpion envenomation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Resolution of signs and symptoms of scorpion envenomation
Time Frame: after treatment (expected average of 12 hrs)
Secondary Outcomes
- Evaluate the adverse events in every treated child(inmediately after treatment and until 5 days later)
Investigators
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