Compare Two Anti-Scorpion Venom Serum In Children

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

Status and phase: Completed; Phase 3

Conditions: Scorpion Sting

Treatments: Biological: Anti-scorpion venom serum Alacramyn; Biological: Anti-scorpion venom serum Birmex

Study type: Interventional

Funder types: Other

Identifiers

NCT01415830

BIRMEX-ECA-03-2011

Details and patient eligibility

About

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).

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Anti-scorpion venom serum Birmex

Experimental group

Description:

Patients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex

Treatment:

Biological: Anti-scorpion venom serum Alacramyn

Anti-scorpion venom serum Alacramyn

Active Comparator group

Description:

Patients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)

Treatment:

Biological: Anti-scorpion venom serum Birmex