Physical Examination in Pharmacokinetics of Antistaphylococcal Antibiotics in Infants - Ticarcillin

Physical Examination 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 ticarcillin-clavulanate are reported here. Fifteen premature infants <30 weeks gestational age were enrolled under ticarcillin-clavulanate, all of whom reported at least one evaluable fresh plasma sample for PK analysis. All participants were included in the safety population. One mild adverse event was reported which was unrelated to ticarcillin-clavulanate. A total of 15 premature infants, <91 days postnatal age and <30 weeks gestational age, were enrolled in the ticarcillin-clavulanate cohort of the NICHD-2012-STA01 study. All enrolled participants received at least one dose of ticarcillin-clavulanate.