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Evaluating a Shorter, Rifampicin-Based Treatment for People With Less Severe Tuberculosis Disease

ConditionPulmonary TB
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorHamilton Health Sciences Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Received more than 7 days treatment for index TB episode

Previous treatment for active TB disease in past 12 months

M. tuberculosis with known resistance to rifampicin or isoniazid

Weight < 30 kg at screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extra 600mg of Rifampicin

    Drug

    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.

  • Placebo

    Drug

    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).

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: 16-Week Regimen (Standard of Care Treatment + 600 mg of Rifampicin daily)Experimental treatment 1 intervention
Group B: 24-Week Regimen (Standard of Care Treatment) + Placebo for 16 weeksPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Death

Time frame
72 weeks
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

St George's, University of London

Collaborator

McMaster University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: