Cefazolin for Infections (3gCefPK Trial)

Phase 1

Waitlist Available

Research Sponsored by B. Braun Medical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days with optional visit on day 8

Awards & highlights

No Placebo-Only Group

Summary

This trial involves giving a single dose of the antibiotic cefazolin to adults weighing 120 kg or more who are about to have surgery. The goal is to see how the drug behaves in their bodies and ensure it works effectively to prevent infections. Cefazolin has been widely studied and used for preventing infections during surgery, including in patients with obesity and various types of surgeries.

Eligible Conditions

Infections
Infections and Infestations

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days with optional visit on day 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days with optional visit on day 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days with optional visit on day 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cefazolin plasma concentration following infusion

Secondary study objectives

Clinical Chemistry: ALT

Clinical Chemistry: AST

Clinical Chemistry: Albumin

+34 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cefazolin 3gm InjectionExperimental Treatment1 Intervention

Study drug will be administrated as an infusion over 30 minutes starting approximately 0.5 hours before surgery begins and following institutional guidelines on Day 1 (day of surgery). All subjects will have five (5) individual whole blood samples (4 mL each) collected for the estimation of cefazolin concentration in plasma at the following times after the start of the infusion: 0.5 (+/-10 min) end of infusion, 1 h (+/-15 min), 2 h (+/-15 min), 4 h (+/-15 min), and 8 h (+/-15 min).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cefazolin 3gm for Injection USP and Dextrose Injection USP

2022

Completed Phase 1

~20

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