← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months plus 2 weeks in the intervention arms; 4 months plus 2 weeks in the control arm.

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).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

448 Previous Clinical Trials

158,406 Total Patients Enrolled

1 Trials studying Latent Tuberculosis

1,589 Patients Enrolled for Latent Tuberculosis

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,452,146 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you elaborate on the past experiments conducted with a Rifampin triple dose?

"At present, there are 31 active clinical trials investigating Rifampin triple dose. Of these studies, 11 have reached their Phase 3 stage. While the majority of the research is conducted in Bandung and Alberta, 262 other sites across the world have committed to running this trial."

Answered by AI

What is the participant count for this research project?

"At the present moment, this study is not actively seeking participants. Originally posted on September 20th 2019 and last updated November 16th 2022, it currently does not have any available recruitment opportunities. However, there are 172 clinical trials that require individuals with latent tuberculosis as well as 31 studies enlisting volunteers for Rifampin triple dose treatment."

Answered by AI

Has the administration sanctioned threefold doses of Rifampin?

"Power researchers gave Rifampin triple dose a score of 2, since there is evidence to suggest its safety but no proof yet that it can be effective in treating illness."

Answered by AI

What specific medical conditions may be remedied by a Rifampin triple dose?

"Rifampin triple dose is a common treatment for Methicillin-Resistant Staphylococcus Aureus (MRSA) infections. It may also be used to tackle pruritus, the initial phase of tuberculosis, and nasopharynx issues."

Answered by AI

How many health facilities in Canada are engaged with this clinical experiment?

"Currently, 4 medical sites are participating in the trial. These include Calgary, Vancouver and Montreal amongst others. It is advised that participants choose a location nearby to reduce any potential travel burden associated with enrollment."

Answered by AI

Can you confirm if there are still open slots available to participate in this research?

"At this moment, no new volunteers are being accepted for participation in this trial. This medical research was initially posted on September 20th 2019 and the most recent update occured November 16th 2022. If you seek alternative studies, 172 trials related to latent tuberculosis are actively enrolling patients while 31 clinical sites offer Rifampin triple dose treatments."

Answered by AI

Recent research and studies

The Lancet Infectious DiseasesJournal

High-dose Rifampicin, Moxifloxacin, and SQ109 for Treating Tuberculosis: A Multi-arm, Multi-stage Randomised Controlled Trial

Boeree, Martin J, Norbert Heinrich, Rob Aarnoutse, Andreas H Diacon, Rodney Dawson, Sunita Rehal, Gibson S Kibiki, et al.. 2017. “High-dose Rifampicin, Moxifloxacin, and SQ109 for Treating Tuberculosis: A Multi-arm, Multi-stage Randomised Controlled Trial”. The Lancet Infectious Diseases. Elsevier BV. doi:10.1016/s1473-3099(16)30274-2.

The Lancet Infectious DiseasesJournal

Intensified Regimen Containing Rifampicin and Moxifloxacin for Tuberculous Meningitis: An Open-label, Randomised Controlled Phase 2 Trial

Ruslami, Rovina, A Rizal Ganiem, Sofiati Dian, Lika Apriani, Tri Hanggono Achmad, Andre J van der Ven, George Borm, Rob E Aarnoutse, and Reinout van Crevel. 2013. “Intensified Regimen Containing Rifampicin and Moxifloxacin for Tuberculous Meningitis: An Open-label, Randomised Controlled Phase 2 Trial”. The Lancet Infectious Diseases. Elsevier BV. doi:10.1016/s1473-3099(12)70264-5.

New England Journal of MedicineJournal

One Month of Rifapentine Plus Isoniazid to Prevent Hiv-related Tuberculosis

Swindells, Susan, Ritesh Ramchandani, Amita Gupta, Constance A. Benson, Jorge Leon-Cruz, Noluthando Mwelase, Marc A. Jean Juste, et al.. 2019. “One Month of Rifapentine Plus Isoniazid to Prevent Hiv-related Tuberculosis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1806808.

Antimicrobial Agents and ChemotherapyJournal