Randomized Controlled Trial to Compare Two Anti-scorpion Serums
Phase 4
Completed
- Conditions
- Scorpion Sting
- Interventions
- Biological: serum antiscorpion
- Registration Number
- NCT00739440
- Lead Sponsor
- Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I serum antiscorpion Patients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex II serum antiscorpion Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
- Primary Outcome Measures
Name Time Method Resolution of signs and symptoms of scorpion envenomation after treatment (expected average of 12 hrs)
- Secondary Outcome Measures
Name Time Method Evaluate the adverse events in every treated child inmediately after treatment and until 5 days later