Study Completion in Pharmacokinetics of Antistaphylococcal Antibiotics in Infants - Rifampin

Study Completion Data
Study Description
NICHD-2012-STA01 was a multiple center, open label, multiple-dose pharmacokinetic study. The primary objective of this study was to determine the pharmacokinetics (PK) of rifampin, ticarcillin-clavulanate, and clindamycin in infants to address gaps in pediatric labeling of these drugs. Only the data for rifampin is reported here. Twenty seven participants were enrolled. Overall, a total of 86 plasma concentrations from 22 participants were used to construct the population PK model. Rifampin PK was well characterized by a 1 compartment PK model, only postnatal age (PNA) was retained as significant for clearance. No adverse events were related to rifampin and there were no serious adverse events reported. Rifampin was well tolerated in the study population. In addition, body weight and PNA were significant covariates for clearance, indicating that rifampin in infants should be dosed using weight and PNA. A total of 27 participants were enrolled in the rifampin cohort of the NICHD-2012-STA01 study. All enrolled participants received at least one dose of rifampin.