Randomized Controlled Trial to Compare Two Anti-Scorpion Serums - Full Text View

Sponsored by:	Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Information provided by:	Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
ClinicalTrials.gov Identifier:	NCT00739440

Purpose

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

Condition	Intervention	Phase
Insect Bites	Drug: serum antiscorpion	Phase IV

MedlinePlus related topics: Animal Bites

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum

Further study details as provided by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.:

Primary Outcome Measures:

Measuring of IgG, IgM, IgE [ Time Frame: baseline and 12 hrs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Security of treatment [ Time Frame: baseline and 12 hrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	August 2008
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Patients 15 to 60 years, will receive serum elaborated by Birmex	Drug: serum antiscorpion The dose may be required for the patient according to clinical manifestations and evolution
II: Experimental Patients 15 to 60 years, will receive other commercial serum (Alacramyn)	Drug: serum antiscorpion The dose may be required for the patient according to clinical manifestations and evolution

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.

We evaluate the production of IgG, IgM and IgE through ELISA in baseline measurement and at 12 pm. It will evaluate the levels of IgG, IgM and IgE comparing the treatment groups.

Eligibility

Ages Eligible for Study:	15 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739440

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Jimenez C Ma. Eugenia, PhD

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

More Information

Responsible Party:	BIRMEX ( Ma. Eugenia Jiménez Corona )
Study ID Numbers:	Birmex-01-2008
Study First Received:	August 19, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00739440
Health Authority:	Mexico: Ministry of Health

Study placed in the following topic categories:

Poisoning
Disorders of Environmental Origin
Insect Bites and Stings
Bites and Stings

ClinicalTrials.gov processed this record on January 16, 2009