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Anti-bacterial agent
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
3gCefPK Trial Summary
This trial is testing whether a 3 gram dose of cefazolin given as a 30-minute infusion is safe and effective in adults scheduled for surgery. Five PK samples will be taken from each subject up to 8 hours after the dose.
3gCefPK Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cefazolin plasma concentration following infusion
Secondary outcome measures
Clinical Chemistry: ALT
Clinical Chemistry: AST
Clinical Chemistry: Albumin
+35 more3gCefPK 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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
B. Braun Medical Inc.Lead Sponsor
17 Previous Clinical Trials
586 Total Patients Enrolled
2 Trials studying Infections
36 Patients Enrolled for Infections
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Cefazolin 3gm Injection
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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