Status:
TERMINATED
Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation
Lead Sponsor:
Instituto Bioclon S.A. de C.V.
Conditions:
Snake Bite
Eligibility:
All Genders
6-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose. Evaluate the Utility of th...
Detailed Description
Snake bite Envenomation is a Public Health Problem especially for tropical and subtropical countries. The WHO estimates 40 000 annual deaths in the world for this cause. In México the Ministry of Heal...
Eligibility Criteria
Inclusion
- Men and women 6 to 65 years of age
- Presenting for emergency treatment of snake bite
- Requiring treatment with antivenom
- Informed consent document read and signed by patient (or parent/legal guardian)
- Participation within the last month on any clinical trial
- Arrival to Hospital within 24 hours after the snake bite
Exclusion
- Allergy to horse serum
- Underlying medical conditions that significantly alter coagulation (oral anticoagulants, vitamin K deficiency, hepatic disease)
- Use of AINE 48 hours previously
- Use of any antivenom 2 weeks previously
- Pregnancy or breast-feeding women
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00639951
Start Date
January 1 2008
End Date
March 1 2009
Last Update
July 20 2016
Active Locations (5)
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1
Hermosillo Site
Sonora, Hermosillo, Mexico
2
Nayarit Site
Tepic, Nayarit, Mexico, 63000
3
Hospital Universitario de la UANL "Dr. José Eleuterio González"
Monterrey, Nuevo León, Mexico, 64460
4
Ciudad Valles Site
Ciudad Valles, San Luis Potosí, Mexico