Intrathecal Tetanus Immunoglobulin to Treat Tetanus

NCT02999815 | Completed Phase 1 DMC

• 1 other identifier: 03TS
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

To establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus

Conditions

Tetanus

Keywords

Tetanus

Outcome Measures

Primary Outcomes (1)

• Requirement for mechanical ventilation during ICU stay

  Criteria for mechanical ventilation are oxygen saturation (SpO2) \<90%; or partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) \<250; or excessive spasms necessitating muscle paralysis. These criteria are intended as a guide and the final decision to ventilate a patient rests with the individual doctor responsible for the patient.

  During ICU stay, an average of 3 weeks

Secondary Outcomes (10)

• Duration of ICU stay

  During ICU stay, an average of 3 weeks

• Duration of hospital stay

  During hospital stay, an average of 5 weeks

• Duration of mechanical ventilation

  During hospital stay, an average of 5 weeks

• In hospital and 240 day mortality

  240 days

• In hospital and 240 day disability

  240 days

Study Arms (2)

Human tetanus immunoglobulin

ACTIVE COMPARATOR

Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intrathecal 500 IU

Procedure: Human tetanus immunoglobulin

Intramuscular antitoxin

SHAM COMPARATOR

Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intramuscular 3000 IU OR Equine antiserum - 21,000 units

Procedure: Human tetanus immunoglobulin; Procedure: Intramuscular antitoxin

Interventions

Human tetanus immunoglobulin 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.

Also known as: Human tetanus immunoglobulin (Tetagam-P)

Human tetanus immunoglobulin; Intramuscular antitoxin

Intramuscular antitoxin 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

Intramuscular antitoxin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator

Study Sites (1)

Hospital for Tropical Diseases

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (57)

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• 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.

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MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Minh Yen Lam, MD

  Oxford University Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 21, 2016
• Study Start: February 13, 2017
• Primary Completion: December 31, 2019
• Study Completion: May 1, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Locations

VN (1)