Non-inferiority Trial of Two Snake Antivenoms in CAR (PAVES)

NCT02694952 | Withdrawn DMC

• 1 other identifier: EPICENTRE CAR 2016
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Snake Bites

Outcome Measures

Primary Outcomes (1)

• Number of patients needing a third dose of antivenom, needing a blood transfusion, or dying

  28 days after enrolment

Secondary Outcomes (4)

• Death from any cause

  28 days after enrolment

• Need for blood transfusion

  Will be evaluated at 2, 6, 12, and 24 hours after enrolment and at hospital discharge

• Need for third dose of antivenom

  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

  Will be evaluated at 2, 6, 12, and 24 hours after enrolment

Study Arms (2)

FAV-Africa

ACTIVE COMPARATOR

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.

Biological: FAV-Africa

EchiTabPlus-ICP

EXPERIMENTAL

EchiTabPlus-ICP infusion at enrollment, and then at two and six hours after enrollment, if necessary.

Biological: EchiTabPlus-ICP

Interventions

FAV-Africa BIOLOGICAL

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.

FAV-Africa

EchiTabPlus-ICP BIOLOGICAL

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.

EchiTabPlus-ICP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• known allergy to horses or heterologous proteins of equine origins
• pregnancy
• have received antivenom since the snakebite

Sponsors & Collaborators

• Epicentre: lead
• Medecins Sans Frontieres, Netherlands: collaborator

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Rebecca Grais, PhD

  Epicentre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 1, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share