IMPAACT 2020: Phase II Study of Shortened Oral Treatment for Multidrug-Resistant Tuberculosis in Children (SMaRT Kids)

Study Status Study Restriction

In Development

Non-US

What is IMPAACT 2020?

IMPAACT 2020 is a Phase II, two-arm, open-label study of children with and without HIV who are less than 15 years of age with confirmed or probable tuberculosis (TB) that is resistant to rifampicin. The study is designed to characterize the safety, tolerability, and treatment outcomes of an all-oral, six-month novel regimen. The study will also include a mixed-methods, socio-behavioral component to assess priorities and preferences for TB treatment among a subset of participants and caregivers.

Sites where the study is implemented:

CRS ID Site Name City Country
Site Selection in progress.

Study contacts:

Study Chair: Anthony Garcia-Prats

Study Vice-Chair: Anneke Hesseling

Study Vice-Chair: Simon Schaaf

DAIDS Medical Officer: Tafadzwa Kasambira

DAIDS Medical Officer: Hans Spiegel

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Elizabeth Greene

Clinical Trials Specialist: Katie McCarthy

Clinical Trials Specialist: Nicole Montañez

Community Program Manager: Jonathan Lucas

Data Manager: Kira Bacon

Data Manager: Mattie Bartlett

Data Manager: Amanda Golner

Investigator: Kelly Dooley

Investigator: Pauline Howell

Investigator: Carolyne Onyango

Investigator: Vanessa Rouzier

Investigator: James Seddon

Laboratory Data Manager (LDM): Rachel Bowman

Laboratory Data Manager (LDM): Kyle Whitson

Laboratory Specialist: William Murtaugh

Laboratory Specialist: Samantha Solomon

Laboratory Technologist: Vandana Kulkarni

Protocol Pharmacist: Oladapo Alli

Protocol Pharmacist: Justine Beck

Statistician: Soyeon Kim

Statistician: Leavitt Morrison

TB Civil Society Advocacy Representative: Lindsay McKenna

Westat Representative: Marsha Johnson

Microbiologist: Anne-Marie Demers

Microbiologist: Willy Ssengooba

Pharmacometrician: Mats Karlsson

Pharmacometrician: Elin Svensson

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.