Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
272 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-02-13
Study Completion Date
2020-05-01
Brief Summary
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To establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus
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Detailed Description
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The investigators will conduct a randomised partially-blinded controlled 2x2 factorial trial. First, adults admitted to the Intensive Care Unit at the Hospital for Tropical Diseases Ho Chi Minh City will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive either standard treatment with intramuscular antitoxin alone or with the addition of 500 IU intrathecal human antitoxin. Patients with prior antitoxin treatment and those with contra-indications to lumbar puncture or antitoxin treatment will be excluded.
All patients will receive other standard tetanus treatment as deemed necessary by the attending physicians. Spasms will be treated with benzodiazepines as first-line therapy. Patients with spasms not controlled with benzodiazepines will receive tracheostomy, paralysis, magnesium sulphate and mechanical ventilation. Heart rate, BP, temperature and daily drug use will be recorded throughout the ICU stay. Patients will be followed following discharge from hospital until 240 days for disability/ death.
All patients will receive other standard tetanus treatment as deemed necessary by the attending physicians. Spasms will be treated with benzodiazepines as first-line therapy. Patients with spasms not controlled with benzodiazepines will receive tracheostomy, paralysis, magnesium sulphate and mechanical ventilation. Heart rate, BP, temperature and daily drug use will be recorded throughout the ICU stay. Patients will be followed following discharge from hospital until 240 days for disability/ death.
Conditions
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Tetanus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Caregivers
Investigators
Study Groups
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Human tetanus immunoglobulin
Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intrathecal 500 IU
Group Type
ACTIVE_COMPARATOR
Human tetanus immunoglobulin
Intervention Type
PROCEDURE
Adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive the addition of 500 IU intrathecal human antitoxin.
Intramuscular antitoxin
Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intramuscular 3000 IU OR Equine antiserum - 21,000 units
Group Type
SHAM_COMPARATOR
Human tetanus immunoglobulin
Intervention Type
PROCEDURE
Adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive the addition of 500 IU intrathecal human antitoxin.
Intramuscular antitoxin
Intervention Type
PROCEDURE
First, adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin including a 0.05ml test dose (ie 75 units equine antitoxin or 12.5 IU human antitoxin). Second, participants will be randomized with sham procedure
Interventions
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Human tetanus immunoglobulin
Adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive the addition of 500 IU intrathecal human antitoxin.
Intervention Type
PROCEDURE
Intramuscular antitoxin
First, adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin including a 0.05ml test dose (ie 75 units equine antitoxin or 12.5 IU human antitoxin). Second, participants will be randomized with sham procedure
Intervention Type
PROCEDURE
Other Intervention Names
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Human tetanus immunoglobulin (Tetagam-P)
Eligibility Criteria
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Inclusion Criteria
* All adult patients (≥16 years old) with a clinical diagnosis of generalized tetanus admitted to the intensive care unit (ICU) at the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Exclusion Criteria
* Prior administration of antitoxin during this episode
* Contra-indication to use of human or equine antitoxin
* Contra-indication to lumbar puncture
* Already receiving mechanical ventilation or expected to require this before intrathecal injection can be given
* Pregnancy
* Informed consent not obtained
* Contra-indication to use of human or equine antitoxin
* Contra-indication to lumbar puncture
* Already receiving mechanical ventilation or expected to require this before intrathecal injection can be given
* Pregnancy
* Informed consent not obtained
Minimum Eligible Age
16 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
OTHER
Sponsor Role
collaborator
Oxford University Clinical Research Unit, Vietnam
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Minh Yen Lam, MD
Role: PRINCIPAL_INVESTIGATOR
Oxford University Clinical Research Unit
Locations
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Hospital for Tropical Diseases
Ho Chi Minh City, , Vietnam
Site Status
Countries
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Vietnam
References
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BACKGROUND
Van Hao N, Loan HT, Yen LM, Kestelyn E, Hong DD, Thuy DB, Nguyen NT, Duong HTH, Thuy TTD, Nhat PTH, Khanh PNQ, Dung NTP, Phu NH, Phong NT, Lieu PT, Tuyen PT, Hanh BTB, Nghia HDT, Oanh PKN, Tho PV, Tan Thanh T, Turner HC, van Doorn HR, Van Tan L, Wyncoll D, Day NP, Geskus RB, Thwaites GE, Van Vinh Chau N, Thwaites CL. Human versus equine intramuscular antitoxin, with or without human intrathecal antitoxin, for the treatment of adults with tetanus: a 2 x 2 factorial randomised controlled trial. Lancet Glob Health. 2022 Jun;10(6):e862-e872. doi: 10.1016/S2214-109X(22)00117-6.
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DERIVED
Loan HT, Yen LM, Kestelyn E, Hao NV, Thanh TT, Dung NTP, Turner HC, Geskus RB, Wolbers M, Tan LV, Van Doorn HR, Day NP, Wyncoll D, Hien TT, Thwaites GE, Vinh Chau NV, Thwaites CL. Intrathecal Immunoglobulin for treatment of adult patients with tetanus: A randomized controlled 2x2 factorial trial. Wellcome Open Res. 2018 Nov 5;3:58. doi: 10.12688/wellcomeopenres.14587.2. eCollection 2018.
Reference Type
DERIVED
Other Identifiers
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03TS
Identifier Type: -
Identifier Source: org_study_id
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