Randomized Controlled Trial to Compare Two Anti-scorpion Serums
August 6, 2013 updated by: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum
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
Study Overview
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: I
Patients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex
|
The dose may be required for the patient according to clinical manifestations and evolution
Other Names:
|
|
Experimental: II
Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
|
The dose may be required for the patient according to clinical manifestations and evolution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Resolution of signs and symptoms of scorpion envenomation
Time Frame: after treatment (expected average of 12 hrs)
|
after treatment (expected average of 12 hrs)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the adverse events in every treated child
Time Frame: inmediately after treatment and until 5 days later
|
inmediately after treatment and until 5 days later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jimenez C Ma. Eugenia, PhD, Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
August 19, 2008
First Submitted That Met QC Criteria
August 20, 2008
First Posted (Estimate)
August 21, 2008
Study Record Updates
Last Update Posted (Estimate)
August 7, 2013
Last Update Submitted That Met QC Criteria
August 6, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Birmex-01-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.