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Compare Two Anti-Scorpion Venom Serum In Children

NCT01415830 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-02-07

No results posted yet for this study

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).

Conditions

  • Scorpion Sting

Interventions

BIOLOGICAL

Anti-scorpion venom serum Birmex

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

BIOLOGICAL

Anti-scorpion venom serum Alacramyn

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Ma. Eugenia Jimenez-Corona, PhD · Laboratorios de Biologicos y Reactivos de México SA de CV

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01415830 on ClinicalTrials.gov