Pediatric Cefazolin PK Study
Condition: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is:

      • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years
      (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV)
      delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.

      The secondary objectives of this study are:

        -  To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of
           cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with
           modeling data for adolescents aged 13-17 years (inclusive) and historical data from
           adults receiving a single 2g dose of cefazolin.

        -  To assess the safety of a single dose of cefazolin in children aged 10 to 12 years
           (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX®
           drug delivery system for surgical prophylaxis.
    

Detailed description: 
      This is a multiple-center, open-label, PK study of cefazolin in children aged 10 to 12 years
      (inclusive) receiving 1g or 2 g of cefazolin delivered via the DUPLEX® drug delivery system
      for surgical prophylaxis. Surgery should be expected to last no longer than 3 hours. If a
      second dose of cefazolin is required, the subject will be excluded from the PK analysis and
      additional subjects will be enrolled if necessary to obtain eight evaluable subjects. The
      surgical procedures may be performed in an outpatient or inpatient setting but subjects must
      be available to complete the planned 8-hour PK sampling as noted below. Study drug will be
      administered by continuous infusion over a 30-minute period using an infusion pump. Based on
      weight at Day 1(Day of Surgery) (unless a weight assessment was obtained within the previous
      seven days that by physician judgment is felt to represent a stable weight and not have the
      potential to change such that the subject dose may be affected). Subjects weighing ≥25 kg and
      < 50 kg will receive the 1g dose. Subjects weighing ≥ 50 kg and ≤ 85 kg will receive the 2g
      dose. Dose groups will not be balanced by age or gender. The weight-based dosage regimen that
      will be employed for this study has been selected to assure that subjects will receive a dose
      between 20 and 40 mg/kg body weight, based on Monte Carlo simulations using adult PK data,
      which is consistent with current practice. Blood samples for determination of PK of cefazolin
      will be drawn at the following times: 15 minutes before the start of infusion (baseline), at
      the end of infusion, 15 and 30 minutes and 1 hour, 2 hours, 3 hours, 6 hours, and 8 hours
      after the end of the infusion for a total of nine blood samples. Safety will be assessed by
      monitoring adverse and serious adverse events based on patient history, vital signs, and
      physical examination. Follow-up phone calls will be placed to each subject one week post
      treatment to assess adverse events (AEs) and well-being.
    

Intervention name(s): Cefazolin 1 GM Injection; Cefazolin 2 GM Injection
Intervention type(s): Drug; Drug
Intervention description(s): Subjects weighing ≥25 kg and < 50 kg will receive the 1g dose.; Subjects weighing ≥50 kg to ≤85 kg will receive the 2g dose.
Intervention MeSH terms: Cefazolin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cefazolin, Pediatric