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Research Article

A Randomized Controlled Trial to Optimize Antivenom Therapy for Carpet Viper (Echis romani)–Envenomed Children in Nigeria

Nicholas A. Hamman Kaltungo Snakebite Research Hospital, Gombe State, Nigeria;

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Agom D. Ibrahim Department of Community Medicine, Federal Teaching Hospital, Gombe, Nigeria;

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Muhammad Hamza Infectious & Tropical Diseases Unit, Bayero University, Kano, Nigeria;

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Mahmoud G. Jahun Department of Paediatrics, Bayero University, Kano, Nigeria;

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Musa Micah Kaltungo Snakebite Research Hospital, Gombe State, Nigeria;

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Hadiza A. Lawal Department of Medical Laboratory Sciences, Bayero University, Kano, Nigeria;

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Saidu B. Abubakar Kaltungo Snakebite Research Hospital, Gombe State, Nigeria;

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Garba Iliyasu Infectious & Tropical Diseases Unit, Bayero University, Kano, Nigeria;

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Basheer A. Z. Chedi Department of Pharmacology, Bayero University, Kano, Nigeria;

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Idris Mohammed Immunology & Infectious Diseases Unit, Federal Teaching Hospital, Gombe, Nigeria;

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Robert A. Harrison Centre for Snakebite Research & Intervention, Liverpool School for Tropical Medicine, Liverpool, United Kingdom;

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José-María Gutiérrez Instituto Clodomiro Picado, School of Microbiology, University of Costa Rica, San José, Costa Rica

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Abdulrazaq G. Habib Infectious & Tropical Diseases Unit, Bayero University, Kano, Nigeria;

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DOI:
https://doi.org/10.4269/ajtmh.24-0222
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Ahead of Print
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In an open randomized controlled trial, we compared one vial (10 mL) to two vials (20 mL) of EchiTAb-plus-ICP (EPI) antivenom among children with systemic carpet viper (Echis romani) envenoming of moderate severity in northeastern Nigeria. Systemic envenoming, presenting with incoagulable blood, was diagnosed using the 20-minute whole blood clotting test (20WBCT). Eligible patients with positive 20WBCT whose guardians assented were recruited and randomly allocated to receive either one vial or two vials of EPI administered either as a bolus or as a slow continuous infusion. The primary outcome was permanent restoration of blood coagulability 6 hours after the start of treatment, assessed by the 20WBCT and repeated at 6, 12, 24, and 48 hours after treatment. Secondary outcomes were the incidences of early adverse reactions to antivenom treatment. Initial doses permanently restored blood coagulability at 6 hours in 34/39 (87.2%) of those treated with one vial and 39/41 (95.1%) of those treated with two vials of EPI (P = 0.258). However, the proportion with permanent restoration of clotting at 6 hours among patients randomized to bolus administration was 41 of 42 (97.6%) patients compared with 32 of 38 (84.2%) patients randomized to slow infusion of EPI antivenom (P = 0.049); however, the difference was not sustained through the remaining time points. There was no difference in early adverse reactions between those treated with the two different doses or modes of delivery. We conclude that the one-vial dose compared favorably to two vials of EPI antivenom with regards to effectiveness and safety among children with carpet viper envenoming of moderate severity in Nigeria.

Author Notes

Authors’ contributions: A. G. Habib, B. A. Z. Chedi, M. Hamza, M. G. Jahun, H. A. Lawal, G. Iliyasu, S. B. Abubakar, and A. D. Ibrahim conceived and designed the proposal and protocol for the study. J.-M. Gutiérrez appraised the proposal and protocol. A. G. Habib, A. D. Ibrahim, S. B. Abubakar, and M. Hamza obtained ethics approvals and registered the trial. N. A. Hamman, A. G. Habib, B. A. Z. Chedi, M. Hamza, and M. Micah provided oversight on study implementation. M. Micah was study pharmacist and was supervised by B. A. Z. Chedi. H. A. Lawal trained staff on and standardized the performance of 20WBCT. N. A. Hamman, A. D. Ibrahim, S. B. Abubakar, and M. Micah conducted the study. A. G. Habib, B. A. Z. Chedi, M. Hamza, and G. Iliyasu analyzed the results and wrote the first draft. M. Hamza, J.-M. Gutiérrez, I. Mohammed, and R. A. Harrison critically appraised the study and reviewed the manuscript. All the authors reviewed and approved the final draft.

Financial support: Venom Antivenom Study Project (VASP), Bayero University, Kano, Nigeria.

Disclosures: Formal ethics approval was obtained from the Ethics Committees in the College of Health Sciences, Bayero University Kano BUK/CHS-HREC/184 and the Ministry of Health, Gombe State, Nigeria MOH/ADM/621/V.1/336. The study was registered on the Pan African Clinical Trials Registry PACTR202106915491232.

Conflicts of interest: J.-M. Gutiérrez works at Instituto Clodomiro Picado, where the antivenom used in this trial is manufactured.

Current contact information: Nicholas A. Hamman, Musa Micah, and Saidu B. Abubakar, Kaltungo Snakebite Research Hospital, Kaltungo, Gombe State, Nigeria, E-mails: nicholas.amani4u@gmail.com, musamicah1030@gmail.com, and abuabus@yahoo.com. Agom D. Ibrahim, Department of Community Medicine, Federal Teaching Hospital, Gombe, Nigeria, E-mail: ibrahimdauda.di@gmail.com. Muhammad Hamza, Garba Iliyasu, and Abdulrazaq G. Habib, Infectious & Tropical Diseases Unit, Bayero University, Kano, Nigeria, E-mails: drhamza1020@ymail.com, ilyasug@yahoo.com, and abdulrazaq_habib@yahoo.co.uk. Mahmoud G. Jahun, Department of Paediatrics, Bayero University, Kano, Nigeria, E-mail: mahmoudjah@yahoo.co.uk. Hadiza A. Lawal, Department of Medical Laboratory Sciences, Bayero University, Kano, Nigeria, E-mail: hadeezalawal@gmail.com. Basheer A. Z. Chedi, Department of Pharmacology, Bayero University, Kano, Nigeria, E-mail: b2Chedi@yahoo.com. Idris Mohammed, Immunology & Infectious Diseases Unit, Federal Teaching Hospital, Gombe, Nigeria, E-mail: idris.muhammad42@gmail.com. Robert A. Harrison, Centre for Snakebite Research & Intervention, Liverpool School for Tropical Medicine, Liverpool, United Kingdom, E-mail: robert.harrison@lstmed.ac.uk. Jose-María Gutiérrez, Instituto Clodomiro Picado, School of Microbiology, University of Costa Rica, San José, Costa Rica, E-mail: jose.gutierrez@ucr.ac.cr.

Address correspondence to Abdulrazaq G. Habib, Infectious & Tropical Diseases Unit, Department of Medicine, Bayero University, Kano, Nigeria. E-mail: abdulrazaq_habib@yahoo.co.uk
Copyright:
© American Society of Tropical Medicine and Hygiene 2024
Received:
07 Apr 2024
|
Accepted:
18 May 2024
|
Published Online:
06 Aug 2024
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
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