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Antibiotic

High-Dose Rifampin for Latent Tuberculosis (2R2 Trial)

Phase 2
Waitlist Available
Led By Dick Menzies
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
Adults, and children aged 10 and older who weigh at least 25kg.
Must not have
Rifampin contra-indicated - due to potential drug interactions that are considered too important, or difficult to manage, by health care provider; or due to history of allergy/ hypersensitivity to rifampin, rifabutin or rifapentine.
Children aged 0-9 and children aged 10 or older who weigh less than 25kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months plus 2 weeks in the intervention arms; 4 months plus 2 weeks in the control arm.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a shorter, higher-dose regimen of rifampin is as safe and effective as the standard 4-month regimen to treat latent TB.

Who is the study for?
This trial is for adults and children aged 10 years or older, weighing at least 25kg, with latent TB infection as indicated by a positive skin test or blood assay. They must be eligible for latent TB treatment per Canadian or WHO guidelines. Excluded are those with certain blood test abnormalities, rifampin-resistant contact exposure, prior TB treatment, significant liver enzyme elevations, potential drug interactions with rifampin, allergy to related drugs, or pregnancy.
What is being tested?
The study tests if higher doses of Rifampin (double or triple the standard dose) given for two months can treat latent tuberculosis as safely and effectively as the standard four-month regimen. It's a phase 2b trial where participants are randomly assigned to one of three groups: standard dose for four months; double dose for two months; triple dose for two months. The exact dosage in shorter regimens is blinded.
What are the potential side effects?
Potential side effects include adverse reactions graded on severity from mild to severe (grade 1-5), which could involve changes in white blood cells, platelets or hemoglobin levels and elevated liver enzymes. Specific side effects of Rifampin typically range from gastrointestinal issues to flu-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 10 years old and weigh more than 25kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take Rifampin due to severe side effects or allergies.
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I am either under 10 years old or over 10 and weigh less than 25kg.
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I have been treated for TB in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months plus 2 weeks in the intervention arms; 4 months plus 2 weeks in the control arm.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months plus 2 weeks in the intervention arms; 4 months plus 2 weeks in the control arm. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety measured by Grade 3 to 5 adverse events
Treatment completion (taking 80% of doses within 120% of allowed time)
Secondary study objectives
Efficacy measured during follow-up visits and telephone calls
Safety measured by Grade 1 to 2 adverse events

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: Intervention Arm 2Experimental Treatment1 Intervention
Two months of daily self-administered rifampin at 30 mg/Kg (maximum 1800 mg/day).
Group II: Intervention Arm 1Experimental Treatment1 Intervention
Two months of daily self-administered rifampin at 20 mg/kg (maximum 1200 mg/day).
Group III: Control ArmActive Control1 Intervention
Four months of daily self-administered rifampin at a dose of 10mg per kg per day (maximum 600mg per day).

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
165,576 Total Patients Enrolled
2 Trials studying Latent Tuberculosis
3,389 Patients Enrolled for Latent Tuberculosis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,528,074 Total Patients Enrolled
5 Trials studying Latent Tuberculosis
10,288 Patients Enrolled for Latent Tuberculosis
Dick MenziesPrincipal InvestigatorRI-MUHC
1 Previous Clinical Trials
1,589 Total Patients Enrolled
1 Trials studying Latent Tuberculosis
1,589 Patients Enrolled for Latent Tuberculosis

Media Library

Rifampin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03988933 — Phase 2
Latent Tuberculosis Research Study Groups: Control Arm, Intervention Arm 1, Intervention Arm 2
Latent Tuberculosis Clinical Trial 2023: Rifampin Highlights & Side Effects. Trial Name: NCT03988933 — Phase 2
Rifampin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03988933 — Phase 2
~219 spots leftby Dec 2025
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