Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

Completed · Phase 3

Conditions studied: Infection, Bone Neoplasms

In brief

The Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial is the first ever international multi-center randomized controlled trial in bone cancer surgery. In order to avoid amputation for bone cancer in the leg, complex limb-saving operations are performed. However, infections with devastating complications following surgery are common. Surgeons from across the world will randomize patients to receive either short- or long-duration antibiotic regimens after surgery with the goal of identifying the best regimen to reduce these infections.

Key facts

Study ID

NCT01479283

Run by

McMaster University

People needed

602

Starts

2013-01-01

Expected to finish

2021-03-01

Last updated by the study team

2021-03-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• primary bone malignancies or aggressive benign bone tumors of the femur or tibia, soft-tissue sarcomas which have invaded the femur or tibia, or oligometastatic bone disease of the femur or tibia in a patient expected to live at least one year post-operatively; and
• treatment by surgical excision and endoprosthetic replacement of the femur or tibia.

You may not qualify if…

• current known Methicillin-resistant Staphylococcus Aureus (MRSA) colonization;
• current known Vancomycin Resistant Enterococcus (VRE) colonization;
• documented anaphylaxis or angioedema to penicillin or cefazolin (Ancef);
• current surgical procedure is a revision surgery for implant failure or infection;
• prior local infection within the surgical field of the affected limb;
• current known immunologically-deficient disease conditions (not including recent chemotherapy);
• known renal insufficiency with estimated creatinine clearance (eGRF) of less than 54 mL/min;
• reconstruction to include structural allograft;
• enrolled in a competing study; and
• weight of less than or equal to 45 kg (for sites using cefuroxime only).

Where it is running

• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Stanford University Hospital and Clinics — Redwood City, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Hartford Hospital — Hartford, Connecticut, United States
• University of Florida Health Shands Hospital — Gainesville, Florida, United States
• Emory Orthopaedics and Spine Center — Atlanta, Georgia, United States
• Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Franklin Square Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Albany Medical Center — Albany, New York, United States
• SUNY Upstate University Hospital — East Syracuse, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Long Island Jewish Medical Center | Northwell Health — Queens, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.