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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial tests if the antibiotic ceftaroline can prevent infections in patients having high-risk heart or joint replacement surgeries by killing bacteria before they cause problems. Ceftaroline has been approved for treating certain types of pneumonia and skin infections.

Eligible Conditions
  • Surgical Site Infection

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgical site infection
Secondary study objectives
Drug intolerance
Other infection
Repeat surgery

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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?

Forest LaboratoriesIndustry Sponsor
337 Previous Clinical Trials
88,694 Total Patients Enrolled
University of CincinnatiLead Sponsor
436 Previous Clinical Trials
634,862 Total Patients Enrolled
Alan G Smulian, M.B.B.Ch.Principal InvestigatorUniversity of Cincinnati
~46 spots leftby Nov 2025
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