Pediatric Cefazolin PK Study

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Medical Inc.
• Treatments: Cefazolin

Criteria

Inclusion Criteria:

1. Male and female subjects of 10 to 12 years (inclusive) at the time of screening and who are scheduled for any type of surgery requiring single-dose perioperative cefazolin prophylaxis

2. The subject and the subject's Legal Authorized Representative (LAR) voluntarily agree that the subject will participate in this study and the LAR signs an Institutional Review Board-approved informed consent and Health Insurance Portability and Accountability Act Authorization prior to the performance of any of the screening procedures

Exclusion Criteria:

1. Known allergy or hypersensitivity to beta-lactam/cephalosporin antibiotics, corn or dextrose- containing products or solutions or any of the other ingredients of the Investigational Product (IP)

2. Pregnant or nursing females

3. Subjects with impaired renal function based on the Revised Schwartz Formula using actual body height, i.e., estimated creatinine clearance ≤ 80 mL/minute/1.73m2 (performed at Screening only if test results are not available within 3 months prior to the planned surgical procedure); the Schwartz GFR is:

• GFR = 0.41 x height (cm)

• Serum creatinine (mg/dL)

4. Have surgery scheduled and planned to last > 3 hours

5. Body Weight <25.0 kg or > 85.0 kg

6. Other laboratory tests, obtained as standard of care, that are outside the normal limits according to site's laboratory reference ranges or are considered by the Investigator, to be clinically significant

7. Administration of cefazolin within the past seven days

8. Administration of any medication (e. g., prescription, herbal, over-the-counter medication(s) or dietary supplements) or medication known to interact with the cefazolin that might interfere with the study drug or study procedures

9. Prior medical history of human immunodeficiency virus, hepatitis C virus, or hepatitis B virus

10. Alcohol abuse or drug abuse

11. Received an investigational drug/device within 30 days of the first dose of study drug

12. Clinically relevant medical condition(s) likely to interfere with the evaluation of the trial drug (e.g., pulmonary disease, metabolic disorders, active malignant disease, autoimmune diseases, and cardiovascular disease)

13. Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements

14. Any condition (s) that in the opinion of the PI would compromise the safety of the subject or the quality of the data

15. Unable or unwilling to adhere to the study-specified procedures and restrictions