TASK 011-RPT-Crush:Relative bioavailability of three generic rifapentine and isoniazid compounds when manipulated in adults with latent tuberculosis: a bridge to paediatric dosing needs (“RPT CRUSH”) - Trial PACTR202306775627089

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Summary

Tuberculosis (TB) remains a leading cause of morbidity and mortality globally. The COVID-19 pandemic has dramatically reduced achievements made in TB case detection, prevention and treatment, resulting in an increase in TB-related mortality for the first time in two decades in 2020 (1). Children < 15 years of age accounted for approximately 11% of the global TB case load in 2020 (approximately one million children estimated to develop TB each year), and contribute to a disproportionate 16% of TB related deaths (2). Paediatric TB is preventable and children with TB disease have good treatment outcomes when diagnosed and treated appropriately. Children with TB exposure are at high risk of progression to disease and to severe forms of disease, with the highest risk occurring in children < 2 years of age, children living with HIV and those with malnutrition. Young children are typically exposed to TB in the household and also in the broader community as they become older and more mobile. TB preventive therapy (TPT) significantly reduces the risk of progression of TB infection to active disease in children, adolescents and adults. TPT is effective, safe, well-tolerated and cost-effective, with a long-standing recommendation for TPT in those at high risk of TB by the World Health Organization (WHO). The 3HP regimen (12 weekly doses of rifapentine (RPT) and isoniazid (INH) is a simplified, effective, and approved regimen for TPT. As the development of child-friendly formulations of RPT drugs is lengthy and access is currently limited in the field, there is a clear and immediate need to see whether available and affordable genetic formulations of RPT/INH can be manipulated to enable their use in children. The primary objective of this study is to estimate the relative bioavailability of (RPT) and (INH) following dosing with 1) RPT/INH FDC (MacLeods), 2) RPT/INH FDC (Lupin) or 3) RPT single compound (Lupin) given with INH single compound (Winthrop/Macleods), in water.

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