Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects
Condition: Postoperative Infection
Intervention: Cefazolin 1 g Infusion; Cefazolin 2 g Infusion
Intervention description: 1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg; 2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
Intervention MeSH terms: Cefazolin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender.
Masking: None (Open Label)
Masking description: n/a, this is an open label study
Enrollment: 61.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of
      cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive)
      scheduled for surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The subject is between the ages of 10 and 17 years (inclusive) at the time of giving
             informed consent.

          2. The subject is scheduled for surgery that will last less than 3 hours.

          3. The subject and the subject's legally authorized representative voluntarily agree that
             the subject will participate in this study. In accordance with applicable laws,
             regulations, and institutional review board requirements, the subject signs or orally
             agrees to an age-appropriate assent and the subject's legally authorized
             representative signs both an institutional review board approved informed consent form
             and Health Insurance Portability and Accountability Act authorization prior to the
             performance of any screening procedures.

          4. For subjects who agree to participate in the PK subgroup additional consent will be
             obtained.

          5. The subject weighs (on Day 1) ≥25 kg but <60 kg for inclusion in 1 g dose group.

          6. The subject weighs (on Day 1) ≥60 kg for inclusion in 2 g dose group.

          7. The subject has been scheduled for any type of surgery requiring single dose
             perioperative cefazolin prophylaxis.

        Exclusion Criteria:

          1. Female subjects who are pregnant or lactating/breastfeeding.

          2. Female subjects of childbearing potential who are sexually active and who are not
             willing to use an effective method of birth control during the study period, eg, oral
             contraceptives, double barrier methods, hormonal injectable or implanted
             contraceptives, tubal ligation, or have a partner with a vasectomy.

          3. The subject has impaired renal function based on the revised Schwartz formula.

          4. The subject has a known allergy or hypersensitivity to β lactam/cephalosporin
             antibiotics, penicillins, corn products, or dextrose containing products or solutions,
             or any of the other ingredients of Cefazolin for Injection United States Pharmacopeia
             (USP) and Dextrose Injection USP in DUPLEX.

          5. The subject has abnormal vital signs or an abnormal electrocardiograph (ECG)
             considered by the investigator to be clinically significant.

          6. The subject has a result of any laboratory test (or repeat test, if done), obtained as
             standard of care, that is outside the normal limit of the site's laboratory reference
             range AND is considered by the investigator to be clinically significant.

          7. The subject has a known history of human immunodeficiency virus, hepatitis B, or
             hepatitis C infection.

          8. The subject has a history of alcohol or drug abuse.

          9. The subject has received any other investigational drug/device within 30 days prior to
             the study drug administration.

         10. The subject has a history of or is currently smoking or using nicotine-containing
             substances or electronic cigarettes as determined by medical history or subject's
             verbal report.