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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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7 November 2022 |
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Main ID: |
ISRCTN57194591 |
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Date of registration:
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14/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised, open, comparison of penicillin and metronidazole for the treatment of tetanus
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Scientific title:
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A randomised, open, comparison of penicillin and metronidazole for the treatment of tetanus |
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Date of first enrolment:
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01/04/1993 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN57194591 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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Bangladesh
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Thailand
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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LM
Yen |
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Address:
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c/o Dr Nick Day
Wellcome Unit
Faculty of Tropical Medicine
420/6 Rajvithi Road
10400
Bangkok
Thailand |
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Telephone:
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+66 (0)2 3549172 |
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Email:
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nickd@tropmedres.ac |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Clinical diagnosis of tetanus
2. Aged more than one month
3. Informed consent from patient or attendant relative (if comatose or aged less than 16 years)
Exclusion criteria: Lack of informed consent or age less than one month
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tetanus
Infections and Infestations
Tetanus
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Intervention(s)
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Patients entered into the study were randomised to receive:
1. Benzylpenicillin 2 million units (child 25,000 units/kg) IV six-hourly for seven days
2. Metronidazole 1 g (child):
a. 125 mg age four weeks to less than 12 months
b. 250 mg age one to four years
c. 500 mg age five to 12 years
Rectally (PR) eight-hourly for three days then 12-hourly for four days.
Once the patient could reliably tolerate oral medicines the appropriate dose of penicillin G or metronidazole was given by mouth instead of IV or PR, respectively. Patients who were known to be allergic to penicillin received erythromycin instead.
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Primary Outcome(s)
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The primary endpoint was mortality.
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Secondary Outcome(s)
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The secondary endpoints were recovery times and complication rates.
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Secondary ID(s)
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077166
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Nil known
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Source(s) of Monetary Support
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The Wellcome Trust (UK) (grant ref: 077166)
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/01/1997 |
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URL:
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