Compare Two Anti-Scorpion Venom Serum In Children

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

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

ClinicalTrials.gov Identifier:

NCT01415830

First received: August 8, 2011

Last updated: February 5, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 8, 2011

Last Updated Date

February 5, 2013

Start Date ^ICMJE

August 2011

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Resolution of signs and symptoms of scorpion envenomation [ Time Frame: after treatment (expected average of 12 hrs) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01415830 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the adverse events in every treated child [ Time Frame: inmediately after treatment and until 5 days later ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Compare Two Anti-Scorpion Venom Serum In Children

Official Title ^ICMJE

Randomized Controlled Trial To Evaluate Efficacy And Safety Of The Polyvalent Anti-scorpion Venom Serum Of Birmex Versus Other Commercial Venom Serum In Children Population

Brief Summary

The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency.

On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).

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 0 and 15 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 (Alacramyn).

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)

Condition ^ICMJE

Scorpion Sting

Intervention ^ICMJE

Biological: Anti-scorpion venom serum Birmex
the dose may be required for the patient according to clinical manifestations and evolution

Other Name: anti-scorpion venom serum
Biological: Anti-scorpion venom serum Alacramyn
The dose may be required fot the patient according to clinical manifestations and evolution

Other Name: antiscorpion venom serum

Study Arm (s)

Experimental: Anti-scorpion venom serum Birmex
Patients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex

Intervention: Biological: Anti-scorpion venom serum Alacramyn
Active Comparator: Anti-scorpion venom serum Alacramyn
Patients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)

Intervention: Biological: Anti-scorpion venom serum Birmex

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Scorpion sting
Either sex
Age 1 to 15 years
Signing an informed consent (signed by parent or guardian)
Being residents of the state of Guanajuato

Exclusion Criteria:

Previous treatment with gamma globulin or immunoglobulin
Blood transfusion at any stage of life
Patients treated with drugs that interact with anti-scorpion serum
History or history of sensitivity or intolerance to anti-scorpion serum or horse products
Pregnancy
Any immunodeficiency
Patients who have participated in a research protocol in the previous month.

Gender

Both

Ages

1 Year to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mexico

Administrative Information

NCT Number ^ICMJE

NCT01415830

Other Study ID Numbers ^ICMJE

BIRMEX-ECA-03-2011

Has Data Monitoring Committee

Yes

Responsible Party

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

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ma. Eugenia Jimenez-Corona, PhD

Laboratorios de Biologicos y Reactivos de México SA de CV

Information Provided By

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

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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