drugset / Trial / NCT01284855

Comparison of Two Dose Regimens of Snake Antivenom for the Treatment of Snake Bites Envenoming in Nepal

NCT01284855 ↗

Phase 2 Completed 250 enrolled CTU
RandomizedParallel-groupDouble-blindTreatment

Summary

This study aims at comparing two doses of antivenom in the treatment of snake bite envenoming. It will take place in 3 centers in rural Nepal and will involve 250 snake bite victims presenting with one or more sign of neurotoxic envenoming. The objective of the study is to generate enough scientific evidence to improve Nepal's current national guidelines for the management of snake bites.

Timeline

Start
2011-04
Primary completion
2012-10-15
Completion
2013-03-20

Outcome

Missed primary endpoint

paper The proportions were similar in the low (37 or 48.7%) vs. high (30 or 38.5%) initial dose group (difference = 10·2%, 95%CI [-6·7 to 27·1], p = 0·264). PMID 28510574 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject VINS Polyvalent Antivenom Protein / enzyme biologic 2 unknown Intravenous
Subject VINS Polyvalent Antivenom Protein / enzyme biologic 10 unknown Intravenous