PROJECT

Four-month Shorter Regimen versus 6 months Standard Regimen for Treatment of Drug sensitive TB disease in children aged 1 year to 18 years – Open labelled Randomised Controlled Trial (4M kids)

January 2026 - December 2030

Objectives:

To determine the efficacy, in terms of unfavourable outcome (TB treatment failure, recurrence or death at 12 months post treatment), of moxifloxacin containing 4 months daily regimen (2HRZM/2HRM) in comparison to 6 months of standard daily regimen (2HRZE/4HRE) for treatment of microbiologically confirmed drug-susceptible TB disease in children aged 1 to under 18 years.

Study Overview:

The 4M Kids Trial is a study looking at whether children and adolescents with drug-sensitive tuberculosis can be safely and effectively treated in 4 months instead of the usual 6 months. It compares a shorter treatment which contains moxifloxacin with the current standard 6-month treatment, with the aim of making TB treatment easier for children and improving treatment completion.

Study Approach:

This is a multicentre randomised clinical trial in children with drug-sensitive TB at nine sites, comparing a 4-month moxifloxacin-containing regimen with the standard 6-month regimen. Participants undergo clinical assessments and laboratory investigations during treatment and are followed for 24 months after treatment to assess effectiveness and safety.

Expected Public Health Impact:

If the 4-month regimen is shown to be effective and safe, it could shorten TB treatment for children, reduce treatment burden, and improve adherence and treatment completion, supporting more effective implementation of childhood TB control programmes.