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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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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
NCT00931736 |
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Date of registration:
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01/07/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Randomized Clinical Trial Comparing 4RIF vs. 9INH for LTBI Treatment-effectiveness
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Scientific title:
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A Randomized Clinical Trial of 4 Months of Rifampin vs. 9 Months of Isoniazid for Latent Tuberculosis Infection. Part 3 - Effectiveness |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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6031 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00931736 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Benin
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Brazil
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Canada
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Ghana
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Guinea
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Indonesia
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Korea, Republic of
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Saudi Arabia
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Contacts
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Name:
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Dick Menzies, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McGill University / McGill University Health Centre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult (age 18 years and older) with documented positive TST (or in the absence of TST,
a documented positive QFT) and prescribed 9 months of Isoniazid for LTBI, following
authoritative recommendations.
Exclusion Criteria:
- Patients who were contacts of TB cases known to be resistant to Isoniazid, Rifampin,
or both.
- Known HIV-infected individuals on anti-retroviral agents whose efficacy would be
substantially reduced by Rifampin, unless therapy can safely be changed to agents not
affected by Rifampin.
- Pregnant women - Rifampin and Isoniazid are considered safe in pregnancy but therapy
is usually deferred until 2-3 months post-partum to avoid fetal risk and the potential
for increased hepato-toxicity immediately post partum.
- Patients on any medication with clinically important drug interactions with Isoniazid
or Rifampin, which their physician believes would make either arm contra-indicated.
- Patients with a history of allergy/hypersensitivity to Isoniazid or to Rifampin,
Rifabutin or Rifapentine.
- Patients with active TB. Patients initially suspected to have active TB can be
randomized once this has been excluded.
- Patients who have already started LTBI therapy.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Latent Tuberculosis Infection
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Intervention(s)
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Drug: Rifampin
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Drug: Isoniazid
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Primary Outcome(s)
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Confirmed active TB during 28 months after randomization
[Time Frame: 7 years total with data analysis]
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Secondary Outcome(s)
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Probable and confirmed active TB
[Time Frame: 7 years total with data analysis]
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Rate of Grade 3 & 4 adverse events
[Time Frame: 7 years including data analysis]
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Comparative cost-effectiveness of regimens
[Time Frame: 7 years including data analysis]
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Confirmed active TB in compliant participants
[Time Frame: 7 years total with data analysis]
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Occurrence of drug resistance in confirmed cases of active TB
[Time Frame: 7 years including data analysis]
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Secondary ID(s)
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MCT-94831
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ISRCTN05675547
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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