A Phase 4, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Safety of 1 g of Cefazolin in Pediatric Subjects With a Weight of at Least 25 kg but Less Than 60 kg Scheduled for Surgery and the Safety of 2 g of Cefazolin in Pediatric Subjects With a Weight of at Least 60 kg Scheduled for Surgery
Study ID: STU 032018-068
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. 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 dose of 1-g cefazolin. Subjects with a weight of at least 60 kg will receive a single dose of2-g cefazolin. Dose groups will not be balanced by age or gender. additional subjects may be enrolled if necessary to ensure at least 50 evaluable subjects with complete safety data per dose group complete the study. During the Screening Period (up to 30 days before the study drug administration), all subjects will have screening and baseline examinations performed to ensure their eligibility for the study. Study drug will be administrated on Day 1 (day of surgery) over 30 minutes as an infusion starting 0.5 to 1 hour before surgery begins and following institutional guidelines. Planned surgical procedures may be performed in an outpatient or inpatient setting and are expected to last no longer than 3 hours. if the surgery is unexpectedly extended beyond the 3-hour limit, additional doses of study drug are permitted according to institutional guidelines. Safety will be assessed by monitoring adverse events (aes), physical examination, vital signs, eCGs, and clinical laboratory tests. During the Follow-up Period, a follow-up visit will be performed on Day 8 ((+-)1 day) for safety assessments. in a subset of approximately 40 subjects, 4 PK samples will be obtained to determine the cefazolin plasma concentrations in this population. Pharmacokinetic samples will be obtained at 0.5 to 1.0 hours, 2.0 hours ((+-)15 minutes), 3.0 hours ((+-)15 minutes), and 4.0 hours ((+-)15 minutes) after the start of the study drug infusion. a minimum of 10 of the 40 subjects are planned to be 10 to 13 years old. if the surgery is unexpectedly extended beyond the 3-hour limit and an additional dose of study drug will be administered, best efforts will be made to obtain the 3-hour and possibly the 4-hour PK samples prior to administration of the additional dose of study drug. Pharmacokinetic sample collection will not continue after the administration of an additional dose of study drug. additional subjects may be enrolled if necessary to ensure availability of complete PK data from at least 40 subjects. Subject completion is defined as completion of the follow-up visit or the time of the subject's last data collection. in the cases of an additional dose of study drug, subjects from whom a 3-hour PK sample is obtained prior to administration of the additional dose are considered PK completers. The study consists of a Screening Period of up to 30 days, a Treatment Period on Day 1 (day of surgery), and a Follow-up Period including a visit on Day 8 ((+-)1 day). The maximal study duration for an individual subject will be 39 days.
Each subject must meet all of the following criteria to be enrolled in this study: 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 (LAR) 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, the LAR signs both an institutional review board (IRB)-approved informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) 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.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- PETER SZMUK
B. BRAUN MEDICAL INC
Primary objective: To evaluate the safety of a single 30-minute infusion of a weight-based dose of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery. Secondary objective: To determine the cefazolin plasma concentrations following a single 30-minute infusion of a weight-based dose of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age(inclusive) scheduled for surgery.