Snake Bites Clinical Trial
Official title:
Randomized, Double-blind, Non-inferiority Trial of Two Antivenoms for the Treatment of Snakebite With Envenoming
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.
The study is designed as a randomized, double-blind, non-inferiority trial among patients
suffering envenoming following snakebite in Paoua, Central African Republic. The primary aim
of the study is to assess the non-inferiority of EchiTabPlus-ICP compared to FAV-Africa, at
preventing a composite primary endpoint consisting of death from any cause, need for blood
transfusion or need for a third dose of antivenom.
A total of 196 patients will be individually randomized in a 1:1 ratio to receive FAV-Africa
or EchiTabPlus-ICP.
The first dose of intervention antivenom will be administered at study enrollment, and the
need for further doses will be judged by clinical exam and the 20 minute WBCT, following the
protocol. All other necessary medical care will be provided as per routine in the Paoua
Prefectural Hospital. Study followup and surveillance for adverse events and serious adverse
events will continue until 28 days after the initial dose of antivenom.
Unique identification numbers will be allocated by an individual independent of the study
team using a computer-generated random number list using permuted blocks of random sizes.
Block sizes will not be disclosed to reduce predictability of the random sequence and ensure
allocation concealment. The Site Principal Investigator who will oversee randomization will
be given a set of sequentially numbered silver coated booklets. The Site Principal
Investigator will be instructed to assign the next sequential randomization code noted in
the booklet to each eligible participant as (s)he is enrolled.
Study antivenoms will be prepared by the unblinded study pharmacist, and will be provided to
the clinical staff in identical presentations. Group assignment will remain concealed from
study personnel, investigators, and participants for the entire study period. The Data and
Safety Monitoring Board (DSMB) will also be masked to the group assignment. The DSMB will
remain masked unless otherwise deemed necessary by the DSMB members for any safety related
issues. Investigators conducting the final analysis will remain masked to the group
assignment until the end of the analysis.
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