A Phase 3 interventional study of Extra 600mg of Rifampicin and Placebo in Pulmonary TB, sponsored by Hamilton Health Sciences Corporation. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Hamilton Health Sciences Corporation · Phase 3, Interventional, and Treatment
RIFAstrat is a Phase 3, double-blind, placebo-controlled, non-inferiority trial to compare the 6-month standard treatment for DS-TB with a 4-month optimised- rifampicin based regimen provided to individuals with limited disease severity.
RIFAstrat is a Phase 3, double-blind, placebo-controlled, non-inferiority trial to compare the 6-month standard treatment for DS-TB with a 4-month optimised-rifampicin based regimen provided to individuals with limited disease severity.
Participants are eligible for the study if they are ≥12 years old with newly diagnosed rifampicin-susceptible pulmonary TB confirmed by rapid molecular testing (Xpert MTB/RIF or ultra) with a limited disease phenotype, defined as a cycle threshold on sputum Xpert MTB/RIF or Ultra corresponding to 'medium' or below for bacterial burden at screening. Broad eligibility criteria allow for enrolment of people living with HIV, diabetes, other common comorbidities.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Hamilton Health Sciences Corporation is the lead sponsor of 242 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For participants living with :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Optimised regimen consisting of rifampicin at 20 mg/kg and isoniazid for 4 months (16 weeks), plus pyrazinamide and ethambutol for the first 2 months (2R20HZE/2R20H). Delivered as local standard of care (RHZE) plus 600mg (2 additional tablets) of rifampicin.
Drug: Extra 600mg of Rifampicin
The standard treatment regimen for DS-TB (rifampicin at 10 mg/kg and isoniazid for 6 months, plus pyrazinamide and ethambutol for the first 2 months; 2RHZE/4RH), with additional placebo for the first 4 months (16 weeks).
Drug: Placebo
Intervention group participants will receive standard treatment (RHZE), plus an optimised regimen consisting of RIfampicin at 20 mg/kg (additional 600mg rifampicin in each weight band) during a shortened treatment period of 16 weeks.
Also known as: Experimental
The standard treatment regimen for DS-TB (rifampicin at 10 mg/kg and isoniazid for 6 months, plus pyrazinamide and ethambutol for the first 2 months; 2RHZE/4RH), with additional placebo for the first 4 months (16 weeks).
Also known as: Control
Proportion of participants with an unfavourable efficacy outcome (treatment failure, recurrence or re-treatment for poor treatment response) through week 48 in the intention to treat population.
Time frame: From enrollment through to Week 48.
Death
Time frame: 72 weeks
Treatment-emergent adverse events
Any adverse event leading to premature, permanent discontinuation of a study drug. Treatment-related adverse events of special interest. Treatment-related SAEs.
Time frame: 14 days after end of randomised treatment
Proportion of participants experiencing symptoms of interest during assigned treatment (tolerability)
Proportion of participants experiencing symptoms of interest during assigned treatment (tolerability)
Time frame: 14 days after end of randomised treatment
Proportion of participants temporarily discontinuing assigned treatment (tolerability)
Proportion of participants temporarily discontinuing assigned treatment (tolerability)
Time frame: 14 days after end of randomised treatement
Proportion of participants permanently discontinuing assigned treatment (tolerability)
Proportion of participants permanently discontinuing assigned treatment (tolerability)
Time frame: 14 days after end of randomised treatment
Percentage of treatment doses taken (adherence)
Percentage of treatment doses taken (adherence)
Time frame: 48 weeks
Total Time on Treatment
Total Time on Treatment
Time frame: 72 weeks
Proportion of participants with acquired (post-baseline) drug resistance
Proportion of participants with acquired (post-baseline) drug resistance
Time frame: 72 weeks
Scores on 5-level EQ-5D questionnaire
Scores on 5-level EQ-5D questionnaire
Time frame: 72 weeks
Catastrophic costs and cost-effectiveness ratios, calculated using the adapted WHO patient costs survey
Catastrophic costs and cost-effectiveness ratios, calculated using the adapted WHO patient costs survey
Time frame: 72 weeks
Respiratory disability measured by Medical Research Council (MRC) Dyspnea scale
Respiratory disability measured by Medical Research Council (MRC) Dyspnea scale
Time frame: 72 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Jan 2029, 35 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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