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About the Authors:
Emilie Alirol
* E-mail: [email protected]
Current address: Global Antibiotics R&D Partnership (GARDP) at Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland
Affiliation: Division of Tropical and Humanitarian Medicine, University Hospitals of Geneva, Geneva, Switzerland
ORCID http://orcid.org/0000-0001-8691-3991
Sanjib Kumar Sharma
Affiliation: B.P. Koirala Institute of Health Sciences, Dharan, Nepal
Anup Ghimire
Affiliation: B.P. Koirala Institute of Health Sciences, Dharan, Nepal
Antoine Poncet
Affiliation: Clinical Research Centre, University Hospitals of Geneva, Geneva, Switzerland
Christophe Combescure
Affiliation: Clinical Research Centre, University Hospitals of Geneva, Geneva, Switzerland
Chabilal Thapa
Affiliation: Dumkauli Primary Health Care Centre, Nawalparasi, Nepal
Vijaya Prasad Paudel
Affiliation: Bharatpur Hospital, Chitwan, Nepal
Kalidas Adhikary
Affiliation: Bharatpur Hospital, Chitwan, Nepal
Walter Robert Taylor
Affiliations Division of Tropical and Humanitarian Medicine, University Hospitals of Geneva, Geneva, Switzerland, Mahidol Oxford Research Unit, Bangkok, Thailand
David Warrell
Affiliation: Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom
Ulrich Kuch
Affiliation: Institute of Occupational Medicine, Social Medicine and Environmental Medicine, Goethe University, Frankfurt am Main, Germany
François Chappuis
Affiliation: Division of Tropical and Humanitarian Medicine, University Hospitals of Geneva, Geneva, SwitzerlandAbstract
Background
Currently, there is inadequate evidence on which to base clinical management of neurotoxic snakebite envenoming, especially in the choice of initial antivenom dosage. This randomised controlled trial compared the effectiveness and safety of high versus low initial antivenom dosage in victims of neurotoxic envenoming.
Methodology/ Principal findings
This was a balanced, randomised, double-blind trial that was conducted in three health care centers located in the Terai plains of Nepal. Participants received either low (two vials) or high (10 vials) initial dosage of Indian polyvalent antivenom. The primary composite outcome consisted of death, the need for assisted ventilation and worsening/recurrence of neurotoxicity. Hourly evaluations followed antivenom treatment. Between April 2011 and October 2012, 157 snakebite victims were enrolled, of which 154 were analysed (76 in the low and 78 in the high initial dose group). Sixty-seven (43·5%) participants met the primary outcome definition. The proportions were similar in the low (37 or 48.7%) vs. high (30 or 38.5%) initial dose group (difference = 10·2%, 95%CI [-6·7 to 27·1], p = 0·264). The mean number of vials used was similar between treatment groups. Overall, patients bitten by kraits did worse than those bitten by cobras. The...