NCT07118696Not yet recruitingPhase 3
Evaluating a Shorter, Rifampicin-Based Treatment for People With Less Severe Tuberculosis Disease
Shortening TB Treatment With Optimised Rifampicin-Based Therapy and Disease Stratification: A Pragmatic Phase 3 Double-Blind Placebo-Controlled Randomised Trial (RIFAstrat)
Source: ClinicalTrials.gov · Last updated 12 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 25 Jul 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Hamilton Health Sciences Corporation
- Diseases
- Tuberculosis
- NCT number
- NCT07118696
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- From 1 Feb 2026 to the primary completion date, 31 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received more than 7 days treatment for index TB episode
- Previous treatment for active TB disease in past 12 months
- For participants of child-bearing potential: currently pregnant or not currently pregnant but unwilling to practice an effective method of contraception during study drug treatment
Other illness
- M. tuberculosis with known resistance to rifampicin or isoniazid
- Sick with one or more WHO 'danger signs' at screening (respiratory rate \> 30 breaths per minute, temperature \> 39 ˚C, heart rate \> 120 bpm, inability to walk unaided)
- For participants living with HIV:
- Urinary lipoarabinomannan test positive at screening
- Requires protease inhibitor-based antiretroviral therapy, and/or long acting antiretrovirals cabotegravir/rilpivirine
- Clinical evidence of acute hepatitis or advanced chronic liver disease (e.g. jaundice, signs of portal hypertension)
- Known end stage renal failure
- Active malignancy not in remission or had systemic chemotherapy within 2 years (except for non-melanomatous skin cancer)
- Contraindication to study medications because of known allergy or intolerance or unavoidable drug-drug interaction
- Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest
Other
- Weight \< 30 kg at screening
- Suspected or confirmed extra-pulmonary TB involving the central nervous system, bones, joints, abdomen, and/or pericardium (coexistent pleural or lymph node TB are not exclusions)
- Inability to attend follow up visits
Who the study is looking for
- Aged 12 years and over
- Clinical and/or radiological evidence of pulmonary TB
- At least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF or Ultra within 30 days of screening confirming rifampicin-sensitive TB
- Have limited TB disease defined as having a cycle threshold on sputum Xpert MTB/RIF or Ultra corresponding to 'medium' or below for bacterial burden at screening (where results from more than one test are available at screening, eligibility will be determined by the highest grade)
- Documentation of HIV status from a validated test performed within 30 days of screening or known to be HIV-positive
- Well enough to be treated as an outpatient
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.