150
Participants
Start Date
April 30, 2015
Primary Completion Date
January 31, 2016
Study Completion Date
March 31, 2016
Azithromycin
Adults (\>18 yrs): 3 x 500mg tablets daily for 5 days; Children (6 months to \<18 yrs): 30mg/kg (oral suspension) daily for 5 days
Sunitinib and Erlotinib
Sunitinib - Adults (\>18 yrs): 1 x 50mg tablet daily for 7 days; Children (6 months to \<18 yrs): 0.83 mg/kg (oral suspension) daily for 7 days. Erlotinib - Adults (\>18 yrs): 1 x 150mg tablet daily for 7 days; Children (8kg to \<20kg): 3.5 mg/kg daily for 7 days; Children (\>20kg to \<30kg): 3.0 mg/kg daily for 7 days; Children (\>30kg to \< 18 yrs): 25 mg/kg daily for 7 days
Atorvastatin and Irbesartan
Atorvastatin - Adults (\>18 yrs): 1 x 40mg tablet daily until discharge; Children (6 years to \<18 yrs): 1 x 40mg tablet daily until discharge; Irbesartan - Adults (\>18 yrs): 1 x 150mg tablets daily until discharge; Children (6 years to \<18 yrs): 1 x 75mg tablet daily until discharge.
IV fluids and laboratory testing
All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
Lead Sponsor
Collaborators (2)
Bill and Melinda Gates Foundation
OTHER
Duke University
OTHER
University of Sierra Leone
OTHER
Syneos Health
OTHER
University of North Carolina
OTHER
Clinical Research Management, Inc.
INDUSTRY