Randomized Controlled Trial to Compare Two Anti-scorpion Serums

Scorpion Sting Clinical Trial

Official title:

Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739440
• Other study ID #: Birmex-01-2008
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2008
• Last updated: August 6, 2013
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: August 2013
• Source: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scorpion Sting
• Scorpion Stings

Intervention

Biological:
• serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of signs and symptoms of scorpion envenomation		after treatment (expected average of 12 hrs)	No
Secondary	Evaluate the adverse events in every treated child		inmediately after treatment and until 5 days later	Yes