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

NCT03231228 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: HC-G-H-1601
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Postoperative Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events [Safety]

  Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.

  8 days

Secondary Outcomes (1)

• Cefazolin Plasma Concentration Following Infusion

  Up to 4 hours after start of study drug infusion

Study Arms (2)

Cefazolin 1 g Infusion

ACTIVE COMPARATOR

Pediatric surgical subjects weighing at least 25 kg to less than 60 kg will receive a single 30-minute infusion of 1 g cefazolin.

Drug: Cefazolin 1 g Infusion

Cefazolin 2 g Infusion

ACTIVE COMPARATOR

Pediatric surgical subjects weighing at least 60 kg will receive a single 30-minute infusion of 2 g cefazolin.

Drug: Cefazolin 2 g Infusion

Interventions

Cefazolin 1 g Infusion DRUG

1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg

Cefazolin 1 g Infusion

Cefazolin 2 g Infusion DRUG

2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg

Cefazolin 2 g Infusion

Eligibility Criteria

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

You may qualify if:

• The subject is between the ages of 10 and 17 years (inclusive) at the time of giving informed consent.
• The subject is scheduled for surgery that will last less than 3 hours.
• 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.
• For subjects who agree to participate in the PK subgroup additional consent will be obtained.
• The subject has been scheduled for any type of surgery requiring single dose perioperative cefazolin prophylaxis.

You may not qualify if:

• Female subjects who are pregnant or lactating/breastfeeding.
• 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.
• The subject has impaired renal function based on the revised Schwartz formula.
• 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.
• The subject has abnormal vital signs or an abnormal electrocardiograph (ECG) considered by the investigator to be clinically significant.
• 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.
• The subject has a known history of human immunodeficiency virus, hepatitis B, or hepatitis C infection.
• The subject has a history of alcohol or drug abuse.
• The subject has received any other investigational drug/device within 30 days prior to the study drug administration.
• 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.

Sponsors & Collaborators

• B. Braun Medical Inc.: lead

Study Sites (5)

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

Location

University of Missouri Health Care System

Columbia, Missouri, 65212, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

Related Links

• Ancef (cefazolin for injection) \[package insert\]. GlaxoSmithKline. Research Triangle Park (NC); 2004 \[cited 2016 Jun 08\]
• Cefazolin and Dextrose for Injection \[package insert\]. B. Braun Medical Inc. Bethlehem \[PA\]; revised 10/2015

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Diana Valencia MD
• Organization: B. Braun Medical Inc.

diana.valencia@bbraunusa.com

610-596-2875

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: n/a, this is an open label study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 110 subjects will be enrolled and assigned to 1 of the 2 dose groups in a 1:1 ratio (55 subjects in each group). Subjects with a weight of at least 25 kg but less than 60 kg will receive a single IV dose of 1 g cefazolin. Subjects with a weight of at least 60 kg will receive a single IV dose of 2 g cefazolin. Dose groups will not be balanced by age or gender.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: November 20, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: July 13, 2020
• Results First Posted: March 13, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)