Non-inferiority Trial of Two Snake Antivenoms in CAR (PAVES) (PAVES)
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|ClinicalTrials.gov Identifier: NCT02694952|
Recruitment Status : Withdrawn (Ministry of Health in country did not authorized the conduct of the study)
First Posted : March 1, 2016
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Snake Bites||Biological: FAV-Africa Biological: EchiTabPlus-ICP||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double-blind, Non-inferiority Trial of Two Antivenoms for the Treatment of Snakebite With Envenoming|
|Estimated Study Start Date :||March 2016|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Active Comparator: FAV-Africa
FAV-Africa infusion at enrollment, and then at two and six hours after enrollment, if necessary. To be given as unblinded rescue dose at twelve hours if fourth dose of antivenom necessary.
Polyspecific antivenom immunoglobulin F(ab)'2 fragments of equine origin manufactured by Sanofi Pasteur, S.A., Lyon, France. Per undiluted 1 ml, the multivalent serum contains ≥25 times the LD50 for mice exposed to venom of Bitis gabonica, Bitis arietans, Echis leucogaster, Echis ocellatus, Naja haje, Dendroaspis polylepis, Dendroaspis viridis, and Dendroaspis jamesoni, as well as ≥20 times the LD50 for mice exposed to venom of Naja melanoleuca and Naja nigricollis.
EchiTabPlus-ICP infusion at enrollment, and then at two and six hours after enrollment, if necessary.
Polyspecific antivenom immunoglobulin of equine origin manufactured by the Clodomiro Picado Institute, San Jose, Costa Rica. Each 10 ml of undiluted antivenom contains enough antibody fragments to neutralize 30 mg of Echis ocellatus venom, 20 mg of Bitis arietans venom and 5 mg of Naga nigricollis venom.
- Number of patients needing a third dose of antivenom, needing a blood transfusion, or dying [ Time Frame: 28 days after enrolment ]
- Death from any cause [ Time Frame: 28 days after enrolment ]
- Need for blood transfusion [ Time Frame: Will be evaluated at 2, 6, 12, and 24 hours after enrolment and at hospital discharge ]
- Need for third dose of antivenom [ Time Frame: Will be evaluated at 2, 6, 12, and 24 hours after enrolment and at hospital discharge ]
- Normalization of coagulopathy as measured by the 20 minute whole blood clotting test [ Time Frame: Will be evaluated at 2, 6, 12, and 24 hours after enrolment ]Using 20 min whole blood clotting test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694952
|Study Director:||Rebecca Grais, PhD||Epicentre|