Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile
Condition: Bacterial Infections; Obesity
MeSH terms: Bacterial Infections
Intervention: Clindamycin
Intervention description: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day will be allowed for children receiving clindamycin as part of clinical care.
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bacterial infections; Obesity; pharmacokinetics; clindamycin

Summary:

      The purpose of this study is to better understand how clindamycin works in children who fall
      in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The
      results of the study will help better understand if children in higher BMI ranges process the
      medication differently and whether dosing should be adjusted in these children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  2 years - < 18 years of age at the time of first dose of study drug

          -  Suspected or confirmed infection OR receiving IV clindamycin per routine care

          -  Negative serum pregnancy test (if female and has reached menarche) within 24 hours of
             first dose of study drug and agreement to practice appropriate contraceptive measures,
             including abstinence, from the time of the initial pregnancy test through the last
             dose of study drug

          -  BMI ≥ 85th percentile for age and sex, based on Centers for Disease Control (CDC)
             recommendations

          -  Signed informed consent/Health Insurance Portability and Accountability Act (HIPAA)
             documents by the parent/legal guardian and assent (if applicable)

        Exclusion Criteria:

          -  The following apply only to those who are NOT already receiving clindamycin per
             routine care:

               1. History of hypersensitivity or allergic reaction to clindamycin or lincomycin

               2. History of C. difficile colitis with previous administration of clindamycin

               3. Aspartate aminotransferase (AST) > 120 units/L

               4. Alanine aminotransferase (ALT) > 210 units/L

               5. Total bilirubin > 3 mg/dL

               6. Serum creatinine > 2 mg/dL

               7. Receiving a neuromuscular blocker as part of their therapy

          -  Previous participation in the study

          -  Subject is on prohibited medication or herbal product (see Appendix II)

          -  Subject is receiving extracorporeal life support (ECLS)

          -  Subject is post-cardiac bypass (within 24 hours)

          -  Subject on inotropes/pressors

          -  Any other condition or chronic illness that, in the opinion of the principal
             investigator, makes participation unadvised or unsafe