IMPAACT 2020: Shortened Oral Treatment for Multidrug-Resistant Tuberculosis in Children (SMaRT Kids): A Phase III Randomized Multi-center Trial

Study Status Study Restriction

In Development

Non-US

What is IMPAACT 2020?

IMPAACT 2020 is a Phase III, two-arm, partially randomized, open-label study of HIV-infected and HIV-uninfected children less than 15 years of age with confirmed or probable multidrug-resistant (MDR) tuberculosis (TB) or rifampin mono-resistant (RMR)-TB. The study is designed to compare the efficacy, safety, and tolerability of an all-oral, six-month regimen to an injectable/oral, nine- to twelve-month World Health Organization (WHO) recommended regimen for MDR-TB or RMR-TB-infected children less than 15 years of age.

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: Elizabeth (Betsy) Smith

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Sarah Bradford

Clinical Trials Specialist: Katie McCarthy

Clinical Trials Specialist: Nicole Montanez

Data Manager: Mattie Bartlett

Data Manager: Bonnie Zimmer

Investigator: Kelly Dooley

Investigator: Carolyne Onyango

Investigator: James Seddon

Laboratory Data Manager (LDM): Allison Reding

Laboratory Specialist: William Murtaugh

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

 

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.