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Antibiotic

Infection needing cefazolin for Pharmacokinetics

Phase 1

Waitlist Available

Research Sponsored by Drexel University

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72-96 hours

Awards & highlights

Study Summary

This trial is testing the safety of adding cefazolin to CRRT solution and whether it results in therapeutic cefazolin concentrations in patients.

Eligible Conditions

Pharmacokinetics
Kidney Dialysis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72-96 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72-96 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72-96 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cefazolin serum levels

Trial Design

3Treatment groups

Experimental Treatment

Group I: No infectionExperimental Treatment1 Intervention

c) If a patient is deemed a candidate for CRRT and does not require any anti-microbial therapy, administration of cefazolin via the CRRT solution(s) will occur to solely obtain pharmacokinetic and safety data. For this indication, pharmacokinetic and safety data will be obtained for a 72-96-hour duration.

Group II: Infection not needing cefazolinExperimental Treatment1 Intervention

b) If a patient is deemed a candidate for CRRT and requires therapy with any anti-microbial for a proven or suspected infection not requiring cefazolin as part of the anti-microbial drug regimen, administration of cefazolin via the CRRT solution(s) will occur to solely obtain pharmacokinetic and safety data. For this indication, pharmacokinetic and safety data will be obtained for a 72-96-hour duration.

Group III: Infection needing cefazolinExperimental Treatment1 Intervention

a) If a patient requires antimicrobial therapy for a proven or suspected infection at the time of CRRT initiation or at any time receiving CRRT, they are eligible for inclusion. If cefazolin is part of the empiric or definitive treatment regimen, it will be mixed in the CRRT solution(s) and administered via a continuous infusion to obtain pharmacokinetic and safety data of administering cefazolin via the CRRT solution and infection treatment related data. For this indication, pharmacokinetic and safety data will be obtained for the duration the patient receives cefazolin via the CRRT solution(s) for the proven or suspected infection as dictated by the primary team caring for the patient.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cefazolin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Drexel UniversityLead Sponsor

150 Previous Clinical Trials

47,681 Total Patients Enrolled

The Center for Pediatric PharmacotherapyUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this treatment have government authorization?

"As this is an early-stage clinical trial, the safety of the treatment has been rated a 1 due to the limited evidence supporting its efficacy and security."

Answered by AI

What pathologies can this therapy usually address?

"This medication is routinely used for surgical prophylaxis. Additionally, it can help patients manage skin and subcutaneous tissue infections of bacterial origin as well as pre-operative infectious diseases."

Answered by AI

Are the enrollment timelines for this clinical research still open?

"Clinicaltrials.gov attests to the fact that this research is recruiting a sample of participants. Initially posted on July 18th, 2019 and revised as recently as October 14th 2020 - The study requires volunteer subjects for further exploration."

Answered by AI

What is the projected enrollment figure for this research project?

"Indeed, the online information from clinicaltrials.gov shows that this experiment is still seeking volunteers. It was initially announced on July 18th 2019 and updated most recently on October 14th 2020 with an aim to recruit 20 participants across 1 location."

Answered by AI

Have any other investigations explored this particular treatment modality?

"Presently, there are 17 clinical trials for this intervention in operation with 2 of them being at Phase 3. Most experiments are located in Singapore and New South Wales; however, 151 distinct sites around the world have launched studies centered on this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Therapeutic Drug Monitoring of Cefazolin in Continuous Renal Replacement Therapy

Jeffrey J. Cies,PharmD,MPH,BCPS-AQ ID,BCPPS,FCCP,FCCM,FPPAG 2019. "Safety and Therapeutic Drug Monitoring of Cefazolin in Continuous Renal Replacement Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03672149.