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Cephalosporin

Ceftaroline for Surgical Site Infection (PREVTAROLINE Trial)

Phase 4
Waitlist Available
Led By Alan G Smulian, M.B.B.Ch.
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Informed Consent
Age - 18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

PREVTAROLINE Trial Summary

The study is a randomized double-blinded study comparing ceftaroline to standard of care therapy with cefazolin and vancomycin as surgical prophylaxis for high risk orthopedic and cardiac surgeries. Study participants will be enrolled from those undergoing cardiothoracic surgery involving sternotomy and those undergoing prosthetic joint replacement of either hip or knee. Consenting patients will be randomized 2:1 to receive either ceftaroline or cefazolin/vancomycin. This study will be blinded by the use of placebo vancomycin infusions and placebo cephalosporin infusions. The primary end point will be the development of a surgical site infection within 30 days of surgery.

Eligible Conditions
  • Surgical Site Infection

PREVTAROLINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PREVTAROLINE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical site infection
Secondary outcome measures
Drug intolerance
Other infection
Repeat surgery

PREVTAROLINE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CeftarolineExperimental Treatment1 Intervention
Experimental comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection
Group II: Cefazolin / VancomycinActive Control1 Intervention
Standard of care comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftaroline fosamil
FDA approved

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
427 Previous Clinical Trials
633,871 Total Patients Enrolled
Forest LaboratoriesIndustry Sponsor
337 Previous Clinical Trials
88,679 Total Patients Enrolled
Alan G Smulian, M.B.B.Ch.Principal InvestigatorUniversity of Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~49 spots leftby Mar 2025