Snake Bites Clinical Trial
— PAVESOfficial title:
Randomized, Double-blind, Non-inferiority Trial of Two Antivenoms for the Treatment of Snakebite With Envenoming
Verified date | June 2017 |
Source | Epicentre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Interventional, individually randomized, double (e.g. investigator and participant) blinded, parallel two-arm, non-inferiority trial to assess the efficacy of EchiTabPlus-ICP compared to FAV-Africa for the treatment of snakebite with envenoming.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - present within 72 hours of snakebite - have signs and symptoms of grade 2 envenoming (oedema beyond the elbows or knees, bleeding at site of bite, bleeding from the gums or hematuria) or grade 3 envenoming (oedema to the shoulders or hips, or serious bleeding - epistaxis, hemoptysis, gastrointestinal bleeding) - lack of coagulation of blood at 20 minutes in a dry vacutainer tube (abnormal 20 minute WBCT) Exclusion Criteria: - known allergy to horses or heterologous proteins of equine origins - pregnancy - have received antivenom since the snakebite |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Medecins Sans Frontieres, Netherlands |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients needing a third dose of antivenom, needing a blood transfusion, or dying | 28 days after enrolment | ||
Secondary | Death from any cause | 28 days after enrolment | ||
Secondary | Need for blood transfusion | Will be evaluated at 2, 6, 12, and 24 hours after enrolment and at hospital discharge | ||
Secondary | Need for third dose of antivenom | Will be evaluated at 2, 6, 12, and 24 hours after enrolment and at hospital discharge | ||
Secondary | Normalization of coagulopathy as measured by the 20 minute whole blood clotting test | Using 20 min whole blood clotting test | Will be evaluated at 2, 6, 12, and 24 hours after enrolment |
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