NCT02307006

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

December 1, 2014

Last Update Submit

November 30, 2015

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    Surgical site infection rates at either the primary surgical site or any remote surgical site

    30 days

Secondary Outcomes (3)

  • Other infection

    30 days

  • Drug intolerance

    30 days

  • Repeat surgery

    30 days

Study Arms (2)

Ceftaroline

EXPERIMENTAL

Experimental comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection

Drug: Ceftaroline

Cefazolin / Vancomycin

ACTIVE COMPARATOR

Standard of care comparator for surgical peri-operative prophylaxis for procedures at increased risk if MRSA infection

Drug: Cefazolin / Vancomycin

Interventions

CeftarolineDRUG

Surgical prophylaxis

Also known as: Teflaro
Ceftaroline
Cefazolin / VancomycinDRUG

Standard of care surgical prophylaxis

Also known as: Ancef, Vancin
Cefazolin / Vancomycin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent
  • Age - 18 years and older
  • Patients undergoing either hip or knee arthroplasty or cardiac surgery with sternotomy
  • Body mass index (BMI) between 18 and 30 kg/m2 inclusive.
  • Female subjects must have a negative serum pregnancy test and be using appropriate contraception.

You may not qualify if:

  • Pregnancy
  • Hypersensitivity or allergic reaction to any β-lactam antibiotic or vancomycin.
  • Presence of cardiovascular shock,
  • Receipt of chronic concomitant systemic corticosteroids, 40 mg of prednisone equivalent;
  • Severe renal impairment (i.e. Creatinine clearance ≤ 30 mL/min);
  • Significant hepatic impairment (i.e. known acute viral hepatitis, aspartate aminotransferase or alanine aminotransferase concentration 10-fold the upper limit of normal (ULN) or total bilirubin 3-fold the ULN or manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy),
  • Hematological impairment with current or anticipated neutropenia with less than 500 neutrophils/mm3 or thrombocytopenia with platelet count of 60 000 cells/mm3
  • HIV infection which at the time of screening meets 2008 CDC criteria for AIDS.
  • Patients undergoing revision surgery for infected prosthetic joint replacement.
  • Body mass index (BMI) less than 18 or greater than 30 kg/m2.
  • Concurrent antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

West Chester Hospital

West Chester, Ohio, 45069, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

CeftarolineCefazolinVancomycin

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Alan G Smulian, M.B.B.Ch.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan G Smulian, M.B.B. Ch.

CONTACT

513 558-4248smuliang@fuse.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(2)