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Anti-tuberculosis agents

Shorter Regimens for Latent Tuberculosis

Phase 2 & 3
Waitlist Available
Led By Dick Menzies, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Rifampin or rifapentine contra-indicated - due to allergy/hypersensitivity to any rifamycin (rifampin, rifabutin or rifapentine), or, drug interactions too difficult to manage
Pre-enrolment - alanine transaminase (ALT), White Blood Cells, platelets or hemoglobin that correspond to a Grade 3 adverse event (AE)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of the treatment (1 month, 2 months or 4 months)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find a safe and effective treatment for Tuberculosis Prevention. They want to test different treatment regimens that are shorter and easier for patients to complete than the current standard treatment. The study

Who is the study for?
This trial is for individuals with latent TB or at risk of reactivating a TB infection. Participants should be healthy and able to take daily self-administered medication. The study excludes those who cannot follow the treatment plan, have conditions that might interfere with the drug's effectiveness, or are unable to provide informed consent.
What is being tested?
The trial is testing three different TB preventive treatments: a standard dose of rifampin for four months, a double dose of rifampin for two months, and one month of levofloxacin with rifapentine. It aims to find a regimen under two months long that's as safe and tolerable as the four-month reference treatment.
What are the potential side effects?
Possible side effects include liver issues due to rifampin and tendon damage from levofloxacin. Other common reactions may involve digestive discomfort, skin rashes, or flu-like symptoms.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to or cannot take rifampin or rifapentine due to severe drug interactions.
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My blood tests for liver function and blood cell counts are not showing severe problems.
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I have been diagnosed with tuberculosis.
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I have been treated for tuberculosis in the past.
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I am taking medication that affects my heart's rhythm.
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My child is between 0 and 4 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the treatment (1 month, 2 months or 4 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the treatment (1 month, 2 months or 4 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Severe treatment-related Adverse Events (AE)
Secondary study objectives
Active TB is suspected within 26 months of randomization
Assess both health system and patient/family costs
Completion
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 2 months high dose rifampin (2R20)Experimental Treatment1 Intervention
60 doses daily self-administered rifampin at 20 mg/kg/day (max.1200 mg/day)
Group II: 1 month levofloxacin and rifapentine (1LP)Experimental Treatment1 Intervention
30 doses daily self-administered levofloxacin (15 mg/kg/day, max. 750 mg/day and rifapentine (10mg/kg/day, max. 600mg)
Group III: 4 months standard dose rifampin (4R10)Active Control1 Intervention
120 doses daily self-administered rifampin at 10 mg/kg/day (max. 600 mg/day)

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,516,273 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
165,161 Total Patients Enrolled
Dick Menzies, MDPrincipal InvestigatorRI-MUHC
3 Previous Clinical Trials
9,455 Total Patients Enrolled
~1200 spots leftby Apr 2027
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