Status:
COMPLETED
Pediatric Cefazolin PK Study
Lead Sponsor:
B. Braun Medical Inc.
Conditions:
Infections
Eligibility:
All Genders
10-12 years
Phase:
PHASE1
Brief 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 intrave...
Detailed Description
This is a multiple-center, open-label, PK study of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2 g of cefazolin delivered via the DUPLEX® drug delivery system for surgical pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01904357
Start Date
March 1 2013
End Date
September 1 2013
Last Update
July 21 2017
Active Locations (2)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72205
2
Toledo Children's Hospital
Toledo, Ohio, United States, 43606