Laboratory Data Uploads in Pharmacokinetics of Antistaphylococcal Antibiotics in Infants - Clindamycin

Laboratory Data Upload 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 clindamycin is reported here. Twenty one participants were enrolled under clindamycin, all of whom submitted at least one evaluable fresh plasma sample to be included with other protocol study data in various PK analyses. All participants were included in the safety population. No adverse events were related to clindamycin and there were five unrelated serious adverse events reported. Clindamycin was well tolerated in the study population. A total of 21 participants were enrolled in the clindamycin cohort of the NICHD-2012-STA01 study. All enrolled participants received at least one dose of clindamycin.