Intrathecal Tetanus Immunoglobulin to Treat Tetanus

Brief Title

Intrathecal Tetanus Immunoglobulin to Treat Tetanus

Official Title

Intrathecal Immunoglobulin for Treatment of Adult Patients With Tetanus: a Randomized Controlled 2x2 Factorial Trial

Brief Summary

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

Detailed Description

      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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Requirement for mechanical ventilation during ICU stay

Secondary Outcome

 Duration of ICU stay

Condition

Tetanus

Intervention

Human tetanus immunoglobulin

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

272

Start Date

February 13, 2017

Completion Date

May 1, 2020

Primary Completion Date

December 31, 2019

Eligibility Criteria

        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
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Minh Yen Lam, MD, , 

Location Countries

Vietnam

Location Countries

Vietnam

Administrative Informations


NCT ID

NCT02999815

Organization ID

03TS


Responsible Party

Sponsor

Study Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

 Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Study Sponsor

Minh Yen Lam, MD, Principal Investigator, Oxford University Clinical Research Unit


Verification Date

May 2020