Table 2.
Key inclusion/exclusion criteria for the three of studies that reported AAG levels among purportedly infected subjects. (note: the below criteria denote those that were considered for inclusion in our analysis and not necessarily for enrollment purposes for the respective studies)
| Study | Inclusion Criteria | Exclusion Criteria |
|---|---|---|
| STA01a | -suspected systemic infection or receiving clindamycin as per standard or care for treatment of an infectious pathogen -<30 weeks gestational age and <121 days postnatal age |
-urine output <0.5 ml/kg/hr -serum creatinine >1.7 mg/dL - history of allergic reaction to clindamycin |
| PTN POPSb | - patients diagnosed with anaerobic bacteria, Pneumococci, Staphylocci, or Streptococci infections; infections (other types); necrotizing enterocolitis; or skin or soft tissue infections who received clindamycin -<21 years of age |
-pregnancy |
| CLIN01c | -suspected/confirmed infection or receiving clindamycin as per standard or care for treatment of an infectious pathogen -negative serum pregnancy test (if female and has reached menarche) within 24 hours prior to first study drug -body mass index ≥ 85th percentile for age and sex based on the Centers for Disease Control recommendations -2-<18 years of age |
-aspartate aminotransferase (AST) >120 units/L* -alanine aminotransferase (ALT) >210 units/L* -total bilirubin >3 mg/dL* -serum creatinine >2 mg/dL* -receiving neuromuscular blocking agents* -history of allergic reaction to clindamycin* -receiving potent CYP3A4 inhibitors, CYP3A4 inducers, inotropes/pressors, or St. John’s Wort -receiving extracorporeal life support -post cardiac bypass (within 24 hours) *denotes criteria applicable to patients who were not already receiving clindamycin a per standard of care at time of enrollment |
The Pharmacokinetics of Anti-Staphylococcal Antibiotics in Infants Clinical Trial (Staph Trio; NICHD-2012-STA01, ClinicalTrials.gov NCT01728363; IND 115,396)
Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care (PTN POPS; NICHD-2011-POP01, ClinicalTrials.gov NCT01431326; IND 113,645)
Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects with BMI ≥ 85th Percentile (CLIN01; NICHD-2012-CLN01, ClinicalTrials.gov NCT01744730; IND 115,396)