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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.
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

2R2 Trial 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.Check my eligibility
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.See study design
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.

2R2 Trial Eligibility Criteria

Inclusion Criteria

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

2R2 Trial 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

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

2R2 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).

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Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
449 Previous Clinical Trials
158,478 Total Patients Enrolled
1 Trials studying Latent Tuberculosis
1,589 Patients Enrolled for Latent Tuberculosis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,348 Previous Clinical Trials
26,453,789 Total Patients Enrolled
4 Trials studying Latent Tuberculosis
8,488 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
~241 spots leftby May 2025
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