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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Randomised controlled double-blind non-inferiority trial of two antivenoms for Saw-scaled or carpet viper (Echis ocellatus) envenoming in Nigeria
PLoS Neglected Tropical Diseases, Volume 4, No. 7, Article e767, Year 2010
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Description
Background: In West Africa, envenoming by saw-scaled or carpet vipers (Echis ocellatus) causes great morbidity and mortality, but there is a crisis in supply of effective and affordable antivenom (ISRCTN01257358). Methods: In a randomised, double-blind, controlled, non-inferiority trial, ''EchiTAb Plus-ICP'' (ET-Plus) equine antivenom made by Instituto Clodomiro Picado was compared to ''EchiTAb G'' (ET-G) ovine antivenom made by MicroPharm, which is the standard of care in Nigeria and was developed from the original EchiTAb-Fab introduced in 1998. Both are caprylic acid purified whole IgG antivenoms. ET-G is monospecific for Echis ocellatus antivenom (initial dose 1 vial) and ET-Plus is polyspecific for E. ocellatus, Naja nigricollis and Bitis arietans (initial dose 3 vials). Both had been screened by pre-clinical and preliminary clinical dose-finding and safety studies. Patients who presented with incoagulable blood, indicative of systemic envenoming by E. ocellatus, were recruited in Kaltungo, north-eastern Nigeria. Those eligible and consenting were randomly allocated with equal probability to receive ET-Plus or ET-G. The primary outcome was permanent restoration of blood coagulability 6 hours after the start of treatment, assessed by a simple whole blood clotting test repeated 6, 12, 18, 24 and 48 hr after treatment. Secondary (safety) outcomes were the incidences of anaphylactic, pyrogenic and late serum sicknesstype antivenom reactions. Findings: Initial doses permanently restored blood coagulability at 6 hours in 161/194 (83.0%) of ET-Plus and 156/206 (75.7%) of ET-G treated patients (Relative Risk [RR] 1.10 one-sided 95% CI lower limit 1.01; P = 0.05). ET-Plus caused early reactions on more occasions than did ET-G [50/194 (25.8%) and 39/206 (18.9%) respectively RR (1.36 one-sided 95% CI 1.86 upper limit; P = 0.06). These reactions were classified as severe in 21 (10.8%) and 11 (5.3%) of patients, respectively. Conclusion: At these doses, ET-Plus was slightly more effective but ET-G was slightly safer. Both are recommended for treating E. ocellatus envenoming in Nigeria. © 2010 Abubakar et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2910709/bin/pntd.0000767.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2910709/bin/pntd.0000767.s002.doc
Authors & Co-Authors
Abubakar, Isa Sadeeq
Nigeria, Kano
Bayero University
Abubakar, Saidu B.
Nigeria, Gombe State
Kaltungo General Hospital
Habib, Abdulrazaq Garba
Nigeria, Kano
Bayero University
Nasidi, Abdulsalami Salam
Nigeria, Abuja
Federal Ministry of Health
Durfa, N.
Nigeria, Abuja
Federal Ministry of Health
Yusuf, P. O.
Nigeria, Zaria
Ahmadu Bello University
Larnyang, S.
Nigeria, Kano
Bayero University
Garnvwa, J.
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Sokomba, Elijah N.
Nigeria, Jos
University of Jos
Salako, Lateef A.
Nigeria, Ibadan
University of Ibadan
Theakston, Robert David Geoffrey
United Kingdom, Liverpool
Liverpool School of Tropical Medicine
Juszczak, Edmund
United Kingdom, Oxford
University of Oxford Medical Sciences Division
Alder, Nicola
United Kingdom, Oxford
University of Oxford Medical Sciences Division
Warrell, David A.
United Kingdom, Oxford
Nuffield Department of Medicine
Statistics
Citations: 111
Authors: 14
Affiliations: 9
Identifiers
Doi:
10.1371/journal.pntd.0000767
Research Areas
Disability
Study Design
Randomised Control Trial
Study Locations
Multi-countries
Nigeria