Pediatric Cefazolin PK Study

NCT01904357 | Completed Phase 1 DMC

• 1 other identifier: HC-G-H-1202
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Infections

Keywords

Cefazolin, Pediatric

Outcome Measures

Primary Outcomes (1)

• Single dose study to evaluate the pharmacokinetics of Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in pediatric subjects of 10-12 years (inclusive) scheduled for surgery

  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.

  8 hours

Secondary Outcomes (2)

• Single dose study to evaluate the pharmacokinetics of Cefazolin for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System in pediatric subjects of 10-12 years (inclusive) scheduled for surgery

  8 Days

• Safety of Cefazolin Dose of 1g or 2 g in children aged 10-12 years of age

  8 days

Study Arms (2)

Cefazolin 1 GM Injection

ACTIVE COMPARATOR

Subjects weighing ≥25 kg and \< 50 kg will receive the 1g dose.

Drug: Cefazolin 1 GM Injection

Cefazolin 2 GM Injection

ACTIVE COMPARATOR

Subjects weighing ≥50 kg to ≤85 kg will receive the 2g dose.

Drug: Cefazolin 2 GM Injection

Interventions

Cefazolin 1 GM Injection DRUG

Subjects weighing ≥25 kg and \< 50 kg will receive the 1g dose.

Cefazolin 1 GM Injection

Cefazolin 2 GM Injection DRUG

Subjects weighing ≥50 kg to ≤85 kg will receive the 2g dose.

Cefazolin 2 GM Injection

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• B. Braun Medical Inc.: lead

Study Sites (2)

Arkansas Children's Hospital

Little Rock, Arkansas, 72205, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43606, United States

Location

Related Publications (2)

• Nahata MC, Durrell DE, Ginn-Pease ME, King DR. Pharmacokinetics and tissue concentrations of cefazolin in pediatric patients undergoing gastrointestinal surgery. Eur J Drug Metab Pharmacokinet. 1991 Jan-Mar;16(1):49-52. doi: 10.1007/BF03189874.

  PMID: 1936061 BACKGROUND

• Schmitz ML, Blumer JL, Cetnarowski W, Rubino CM. Determination of appropriate weight-based cutoffs for empiric cefazolin dosing using data from a phase 1 pharmacokinetics and safety study of cefazolin administered for surgical prophylaxis in pediatric patients aged 10 to 12 years. Antimicrob Agents Chemother. 2015 Jul;59(7):4173-80. doi: 10.1128/AAC.00082-15. Epub 2015 May 4.

  PMID: 25941220 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Michael L Schmitz, MD

  Arkansas Children's Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 22, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)