51
Participants
Start Date
November 30, 2015
Primary Completion Date
August 31, 2018
Study Completion Date
June 30, 2020
Clindamycin
"Route of administration is IV for all Cohorts. Dosing interval is every 8 hrs. for all Cohorts:~* Cohort 1; No. Subjects = 5; Age 1-5 months; Dose = 9 mg/kg;~* Cohort 2; No. Subjects = 5; Age \>5 months to 1 year; Dose =12 mg/kg;~* Cohort 3; No. Subjects = 5; Age \>1-2 years; Dose =12 mg/kg.~* Cohort 4; No. Subjects = 4; Age \>2-6 years; Dose =12 mg/kg.~* Cohort 5; No. Subjects = 4; Age \>6-12 years; Dose =10 mg/kg.~* Cohort 6; No. Subjects = 4; Age \>12-16 years; Dose =10 mg/kg."
trimethoprim-sulfamethoxazole
"Route of administration is PO for all Cohorts. Dosing interval is every 12 hrs. for all Cohorts:~* Cohort 1; No. Subjects = 5; Age 1-5 months; Dose = 6 mg/kg.~* Cohort 2; No. Subjects = 5; Age \>5 months to 1 year; Dose = 6 mg/kg.~* Cohort 3; No. Subjects = 5; Age \>1-2 years; Dose = 6 mg/kg.~* Cohort 4; No. Subjects = 4; Age \>2-6 years; Dose = 6 mg/kg.~* Cohort 5; No. Subjects = 4; Age \>6-12 years; Dose = 6 mg/kg.~* Cohort 6; No. Subjects = 4; Age \>12-16 years; Dose = 4 mg/kg."
University of Michigan C.S. Mott Children's Hospital, Ann Arbor
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago
Arkansas Children's Hospital, Little Rock
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Michael Cohen-Wolkowiez
OTHER