Compare Two Anti-Scorpion Venom Serum In Children

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01415830

Enrollment

120

Registered

2011-08-12

Start date

2011-08-31

Completion date

2012-05-31

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scorpion Sting

Keywords

Anti-Scorpion venom serum, venom, efficacy, safety, children

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).

Interventions

BIOLOGICALAnti-scorpion venom serum Birmex

the dose may be required for the patient according to clinical manifestations and evolution

BIOLOGICALAnti-scorpion venom serum Alacramyn

The dose may be required fot the patient according to clinical manifestations and evolution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 15 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026