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Randomized Controlled Trial to Compare Two Anti-scorpion Serums

Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00739440
Enrollment
120
Registered
2008-08-21
Start date
2008-08-31
Completion date
2008-11-30
Last updated
2013-08-07

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

Conditions

Scorpion Sting

Brief summary

The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum

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 15 and 60 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.

Interventions

BIOLOGICALserum antiscorpion

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Sting scorpion * Informed consent * Age 15-60 * Either sex * Resident in study area

Exclusion criteria

* Previous treatment with gammaglobulin * Blood transfusion at any stage of life * Sensitivity or intolerance to serums antiscorpion or horse products * Pregnancy * Some immunodeficiency

Design outcomes

Primary

MeasureTime frame
Resolution of signs and symptoms of scorpion envenomationafter treatment (expected average of 12 hrs)

Secondary

MeasureTime frame
Evaluate the adverse events in every treated childinmediately after treatment and until 5 days later

Outcome results

None listed

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