Pediatric Cefazolin PK Study

Completed · Phase 1

Conditions studied: Infections

In brief

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.

Key facts

Study ID

NCT01904357

Run by

B. Braun Medical Inc.

People needed

12

Starts

2013-03-01

Expected to finish

2013-09-01

Last updated by the study team

2017-07-21

Who can join

Age: 10 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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)
• Pregnant or nursing females
• 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)
• Have surgery scheduled and planned to last > 3 hours
• Body Weight <25.0 kg or > 85.0 kg
• 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
• Administration of cefazolin within the past seven days
• 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
• Prior medical history of human immunodeficiency virus, hepatitis C virus, or hepatitis B virus
• Alcohol abuse or drug abuse
• Received an investigational drug/device within 30 days of the first dose of study drug
• 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)
• Any planned medical intervention or personal event that might interfere with the ability to comply with the study requirements
• Any condition (s) that in the opinion of the PI would compromise the safety of the subject or the quality of the data
• Unable or unwilling to adhere to the study-specified procedures and restrictions

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Toledo Children's Hospital — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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