Compare Two Anti-Scorpion Venom Serum In Children

Scorpion Sting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415830
• Other study ID #: BIRMEX-ECA-03-2011
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2011
• Last updated: February 5, 2013
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: February 2013
• Source: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico:Federal Commission for Sanitary Risks Protection (COFEPRIS)
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

Inclusion Criteria:

1. Scorpion sting

2. Either sex

3. Age 1 to 15 years

4. Signing an informed consent (signed by parent or guardian)

5. Being residents of the state of Guanajuato

Exclusion Criteria:

1. Previous treatment with gamma globulin or immunoglobulin

2. Blood transfusion at any stage of life

3. Patients treated with drugs that interact with anti-scorpion serum

4. History or history of sensitivity or intolerance to anti-scorpion serum or horse products

5. Pregnancy

6. Any immunodeficiency

7. Patients who have participated in a research protocol in the previous month.

Study Design

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

Related Conditions & MeSH terms

• Scorpion Sting
• Scorpion Stings

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital General Regional de León	León	Guanajuato

Sponsors (1)

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

Country where clinical trial is conducted

Mexico, 

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