Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects

• Status: Terminated
• Trial end date: 2019-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

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.