MedTrace Logo

The Use of Ceftaroline as Surgical Prophylaxis in Surgery With Risk of MRSA Infection

NCT02307006 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2015-12-02

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

Interventions

DRUG

Ceftaroline

Surgical prophylaxis

DRUG

Cefazolin / Vancomycin

Standard of care surgical prophylaxis

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Alan G Smulian, M.B.B.Ch. · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02307006 on ClinicalTrials.gov