A Pilot Study to Assess Safety and Feasibility of Intrathecal Immunoglobulin for the Treatment of Adults with Tetanus

Tetanus remains a significant burden in many low- and middle-income countries. The tetanus toxin acts within the central nervous system and intrathecal antitoxin administration may be beneficial, but there are safety concerns, especially in resource-limited settings. We performed a pilot study to as...

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Published in:The American journal of tropical medicine and hygiene Vol. 99; no. 2; pp. 323 - 326
Main Authors: Loan, Huynh Thi, Yen, Lam Minh, Kestelyn, Evelyne, Hao, Nguyen Van, Mai, Nguyen Thi Hoang, Thuy, Duong Bich, Duong, Ha Thi Hai, Dung, Nguyen Thi Phuong, Phu, Nguyen Hoan, Lieu, Pham Thi, Thanh, Tran Tan, Geskus, Ronald, van Doorn, H Rogier, Tan, Le Van, Wyncoll, Duncan, Day, Nicholas P J, Hien, Tran Tinh, Thwaites, Guy E, Chau, Nguyen Van Vinh, Thwaites, C Louise
Format: Journal Article
Language:English
Published: United States Institute of Tropical Medicine 01-01-2018
The American Society of Tropical Medicine and Hygiene
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Summary:Tetanus remains a significant burden in many low- and middle-income countries. The tetanus toxin acts within the central nervous system and intrathecal antitoxin administration may be beneficial, but there are safety concerns, especially in resource-limited settings. We performed a pilot study to assess the safety and feasibility of intrathecal human tetanus immunoglobulin in five adults with tetanus before the conduct of a large randomized controlled trial. Intrathecal injection via lumbar puncture was given to all patients within a median 140 (range 100-165) minutes of intensive care unit (ICU) admission. There were no serious adverse effects associated with the procedure although three patients had probably related minor adverse events which resolved spontaneously. Median ICU length of stay was 14 (range 5-17) days. Two patients required mechanical ventilation and one developed a deep vein thrombosis. Within 240 days of hospital discharge, no patients died and all patients returned to work.
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Financial support: The study is funded by Wellcome Trust, Grant number107367 to Dr. Catherine Louise Thwaites.
Disclosure: The randomized controlled trial is registered as ClinicalTrials.gov, NCT 02999815. This study has been approved by the Scientific and Ethics Committee of the Hospital for Tropical Diseases, the Ethics Committee of the Ministry of Health, Vietnam and the Oxford Tropical Research Ethics Committee, UK.
Authors’ addresses: Huynh Thi Loan, Ha Thi Hai Duong, and Nguyen Van Vinh Chau, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, E-mails: loanhsuv@gmail.com, haduong200385@yahoo.com.vn, and chaunvv@oucru.org. Lam Minh Yen, Nguyen Thi Phuong Dung, Pham Thi Lieu, Tran Tan Thanh, and Le Van Tan, Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, E-mails: yenlm@oucru.org, dungntp@oucru.org, lieupt@oucru.org, thanhtt@oucru.org, and tanlv@oucru.org. Evelyne Kestelyn, Ronald Geskus, H. Rogier van Doorn, Tran Tinh Hien, Guy E. Thwaites, and C. Louise Thwaites, Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, and Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom, E-mails: ekestelyn@oucru.org, rgeskus@oucru.org, rvandoorn@oucru.org, htt@oucru.org, gthwaites@oucru.org, and lthwaites@oucru.org. Nguyen Van Hao, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, and University of Medicine and Pharmacy, Ho Chi Minh City, Vietnam, E-mail: haodiep61@gmail.com. Nguyen Thi Hoang Mai, Duong Bich Thuy, and Nguyen Hoan Phu, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, and Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, E-mails: mainth@oucru.org, duongicu@gmail.com, and phunh@oucru.org. Duncan Wyncoll, Guy’s and St Thomas’ Hospitals NHS Trust, London, United Kingdom, E-mail: duncan.wyncoll@gstt.nhs.uk. Nicholas P. J. Day, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, United Kingdom, and Mahidol Oxford Research Unit, Bangkok, Thailand, E-mail: nickd@tropmedres.ac.
ISSN:0002-9637
1476-1645
DOI:10.4269/ajtmh.18-0153