TABLE 1

Demographic and clinical characteristics for participants in the CLIN01, PTN POPS, and Staph Trio trialsa

CovariateValue in study
CLIN01 (n = 21)PTN POPS (n = 178)Staph Trio (n = 21)
Ageb13.0 (6.5–17.4)5 (0.01–20.5)23 (5–65)
Wt (kg)69.5 (27.9–224)23.0 (0.5–139.8)1.0 (0.5–3.0)
BMI (kg/m2)27.1 (18.6–74)24.8 (13.7–46.7)NA
SCR (mg/dl)0.6 (0.3–1.5)0.4 (0.1–3.4)0.7 (0.2–1.5)
AST (U/liter)25 (8–151)35.5 (8–389)25 (15–116)
ALT (U/liter)25 (10–114)31.5 (5–266)11 (6–55)
TBIL (mg/dl)0.5 (0.2–3.8)1.1 (0–11)4.7 (0.5–8.2)
Albumin (g/dl)3.7 (2.1–4.6)3.3 (1.9–4.5)2.3 (1.3–2.8)
AAG (mg/ml)2.0 (0.5–3.8)2.5 (0.5–6.3)0.8 (0.4–1.8)
  • a Data are medians (ranges). Descriptive statistics are calculated based on values at the time of first recorded dose. PTN POPS, Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care; CLIN01, Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects with BMI ≥ 85th Percentile; Staph Trio, Pharmacokinetics of Antistaphylococcal Antibiotics in Infants; BMI, body mass index; SCR, serum creatinine; AST, aspartate aminotransferase; ALT, alanine transaminase; TBIL, total bilirubin; AAG, alpha-1 acid glycoprotein; NA, not available.

  • b Age is reported in years for CLIN01 and PTN POPS and days for Staph Trio.