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
1 other identifier
interventional
120
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 8, 2011
CompletedFirst Posted
Study publicly available on registry
August 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFebruary 7, 2013
February 1, 2013
9 months
August 8, 2011
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resolution of signs and symptoms of scorpion envenomation
after treatment (expected average of 12 hrs)
Secondary Outcomes (1)
Evaluate the adverse events in every treated child
inmediately after treatment and until 5 days later
Study Arms (2)
Anti-scorpion venom serum Birmex
EXPERIMENTALPatients 0 to 15 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex
Anti-scorpion venom serum Alacramyn
ACTIVE COMPARATORPatients 0 to 15 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
Interventions
the dose may be required for the patient according to clinical manifestations and evolution
The dose may be required fot the patient according to clinical manifestations and evolution
Eligibility Criteria
You may qualify if:
- Scorpion sting
- Either sex
- Age 1 to 15 years
- Signing an informed consent (signed by parent or guardian)
- Being residents of the state of Guanajuato
You may not qualify if:
- Previous treatment with gamma globulin or immunoglobulin
- Blood transfusion at any stage of life
- Patients treated with drugs that interact with anti-scorpion serum
- History or history of sensitivity or intolerance to anti-scorpion serum or horse products
- Pregnancy
- Any immunodeficiency
- Patients who have participated in a research protocol in the previous month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General Regional de León
León, Guanajuato, 37320, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ma. Eugenia Jimenez-Corona, PhD
Laboratorios de Biologicos y Reactivos de México SA de CV
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2011
First Posted
August 12, 2011
Study Start
August 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
February 7, 2013
Record last verified: 2013-02