Intrathecal Tetanus Immunoglobulin to Treat Tetanus

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

February 13, 2017

Primary Completion Date

December 31, 2019

Study Completion Date

May 1, 2020

Conditions
Tetanus
Interventions
PROCEDURE

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.

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

Trial Locations (1)

700000

Hospital for Tropical Diseases, Ho Chi Minh City

All Listed Sponsors
collaborator

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

OTHER

lead

Oxford University Clinical Research Unit, Vietnam

OTHER

NCT02999815 - Intrathecal Tetanus Immunoglobulin to Treat Tetanus | Biotech Hunter | Biotech Hunter