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: Elizabeth Greene |
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): Kyle Whitson |
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 |
Pharmacometrician: Elin Svensson |