Compare Two Anti-Scorpion Venom Serum In Children

Phase 3

Completed

• Conditions: Scorpion Sting

• Registration Number: NCT01415830
• Lead Sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resolution of signs and symptoms of scorpion envenomation	after treatment (expected average of 12 hrs)

Secondary Outcome Measures

Name	Time	Method
Evaluate the adverse events in every treated child	inmediately after treatment and until 5 days later

Trial Locations

Locations (1)

Hospital General Regional de León; 🇲🇽 León, Guanajuato, Mexico