BibTex format
@article{Van:2022,
author = {Van, Hao N and Loan, HT and Yen, LM and Kestelyn, E and Hong, DD and Thuy, DB and Nguyen, NT and Duong, HTH and Diem, Thuy TT and Huy, Nhat PT and Quoc, Khanh PN and Phuong, Dung NT and Hoan, Phu N and Thanh, Phong N and Thi, Lieu P and Thi, Tuyen P and Bich, Hanh BT and Trung, Nghia HD and Nguyet, Oanh PK and Vinh, Tho P and Tan, Thanh T and Turner, H and van, Doorn HR and Van, Tan L and Wyncoll, D and Day, NPJ and Geskus, RB and Thwaites, GE and Vinh, Chau NV and Thwaites, CL},
journal = {The Lancet Global Health},
title = {Human versus equine intramuscular antitoxin, with or without human intrathecal antitoxin, for the treatment of adults with tetanus: a 2x2 factorial randomized control trial},
url = {https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00117-6/fulltext},
volume = {10},
year = {2022}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - Background: Intramuscular antitoxin is recommended in tetanus treatment, but there are few data comparing human and equine preparations. As tetanus toxin acts within the central nervous system, where there is limited penetration of peripherally-administered antitoxin, intrathecal antitoxin administration may improve clinical outcomes compared to intramuscular injection.Methods: In a 2x2 factorial trial, adults with tetanus in a single-centre in Vietnam were randomized first to 3,000 IU human or 21,000 U equine intramuscular antitoxin, then to either 500 IU intrathecal human antitoxin or sham procedure. Interventions were delivered by independent clinicians, with attending clinicians and study staff blind to treatment allocations. The primary outcome was requirement for mechanical ventilation. Secondary outcomes included in-hospital mortality, death and disability at 240-days, duration of intensive care unit (ICU) stay, and adverse events. The study was registered at ClinicalTrials.gov, NCT 02999815 (status: recruitment completed).Findings: 272 adults were randomized. Mechanical ventilation was given to 56/130 (43%) of patients allocated to intrathecal antitoxin and 65/131 (50%) allocated to sham procedure (RR 0.87; 95% CI 0.66 to 1.13; p=0.29). For the intramuscular allocation 48/107 (45%), patients allocated to human antitoxin received mechanical ventilation compared to 48/108 (44%) patients allocated to equine antitoxin (relative risk (RR) 1.01, 95% confidence interval (CI) 0.75, 1.36, p=0.95). No clinically-relevant differences in secondary outcomes or adverse events were seen except for shorter length of ICU stay in those treated with intrathecal antitoxin compared to sham. Interpretation: We found no advantage of intramuscular human antitoxin over intramuscular equine antitoxin in tetanus treatment. Intrathecal antitoxin administration was safe but did not provide overall benefit in addition to intramuscular antitoxin administration.Funding: The Wellcome Trus
AU - Van,Hao N
AU - Loan,HT
AU - Yen,LM
AU - Kestelyn,E
AU - Hong,DD
AU - Thuy,DB
AU - Nguyen,NT
AU - Duong,HTH
AU - Diem,Thuy TT
AU - Huy,Nhat PT
AU - Quoc,Khanh PN
AU - Phuong,Dung NT
AU - Hoan,Phu N
AU - Thanh,Phong N
AU - Thi,Lieu P
AU - Thi,Tuyen P
AU - Bich,Hanh BT
AU - Trung,Nghia HD
AU - Nguyet,Oanh PK
AU - Vinh,Tho P
AU - Tan,Thanh T
AU - Turner,H
AU - van,Doorn HR
AU - Van,Tan L
AU - Wyncoll,D
AU - Day,NPJ
AU - Geskus,RB
AU - Thwaites,GE
AU - Vinh,Chau NV
AU - Thwaites,CL
PY - 2022///
SN - 2214-109X
TI - Human versus equine intramuscular antitoxin, with or without human intrathecal antitoxin, for the treatment of adults with tetanus: a 2x2 factorial randomized control trial
T2 - The Lancet Global Health
UR - https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00117-6/fulltext
VL - 10
ER -