Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
PARITY
1 other identifier
interventional
602
11 countries
53
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2013
Longer than P75 for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
November 24, 2011
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedMarch 11, 2021
March 1, 2021
8.2 years
November 15, 2011
March 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical Site Infections
the development of a surgical site infection according to the criteria established by the Center for Disease Control (CDC)
1 year
Secondary Outcomes (5)
Functional Outcome and Quality of Life
1 year
Antibiotic-Related Complications
1 year
Rate of Re-Operation
1 year
Oncologic Recurrence and/or Metastases
1 year
Mortality
1 year
Study Arms (2)
Short-Arm Antibiotic Regimen
ACTIVE COMPARATORIntervention: 24-Hour Prophylactic Cefazolin\* Antibiotic Regimen \*or another cephalosporin with equivalent gram-positive coverage in centers where cefazolin is not routinely used or not approved for use
Long-Arm Antibiotic Regimen
EXPERIMENTALIntervention: 5-Days Prophylactic Cefazolin\* Antibiotic Regimen \*or another cephalosporin with equivalent gram-positive coverage in centers where cefazolin is not routinely used or not approved for use
Interventions
Pre-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin within 60 minutes prior to the procedure. No other pre-operative antibiotics will be administered. Intra-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin every 3-4 hours. No other intra-operative antibiotics will be administered. Post-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin every 8 hours for 24 hours followed by IV saline for 4 days. No other post-operative antibiotics will be administered.
Pre-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin within 60 minutes prior to the procedure. No other pre-operative antibiotics will be administered. Intra-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin every 3-4 hours. No other intra-operative antibiotics will be administered. Post-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if \< 18 years old) of IV cefazolin every 8 hours for 5 days. No other post-operative antibiotics will be administered.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Orthopedic Research and Education Foundationcollaborator
- The Physicians' Services Incorporated Foundationcollaborator
- Canadian Cancer Society (CCS)collaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (54)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90404, United States
Stanford University Hospital and Clinics
Redwood City, California, 94063, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California San Francisco Medical Center
San Francisco, California, 94118, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
University of Florida Health Shands Hospital
Gainesville, Florida, 32611-2727, United States
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Franklin Square Medical Center
Baltimore, Maryland, 21237, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Albany Medical Center
Albany, New York, 11206, United States
SUNY Upstate University Hospital
East Syracuse, New York, 13057, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Long Island Jewish Medical Center | Northwell Health
Queens, New York, 11040, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
The Cleveland Clinic - Hillcrest Hospital
Cleveland, Ohio, 44195, United States
Wexner Medical Center
Columbus, Ohio, 43210, United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
The Rothman Institute at Jefferson
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Medical Center
Nashville, Tennessee, 37232-8774, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Hospital Universitario Austral
Pilar, Buenos Aires, 1629, Argentina
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
LKH - Universitätsklinikum Graz
Graz, Austria
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Instituto de Ortopedia e Traumatologia
São Paulo, Brazil
Foothills Medical Centre
Calgary, Alberta, T2N 5A1, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E6, Canada
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T4B3, Canada
McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6, Canada
Children's Cancer Hospital Egypt
Cairo, Egypt
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Leiden University Medical Center
Leiden, South Holland, 2333, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Singapore General Hospital
Singapore, Singapore
Grey's Hospital
Pietermaritzburg, South Africa
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Related Publications (7)
Hasan K, Racano A, Deheshi B, Farrokhyar F, Wunder J, Ferguson P, Holt G, Schwartz H, Petrisor B, Bhandari M, Ghert M. Prophylactic antibiotic regimens in tumor surgery (PARITY) survey. BMC Musculoskelet Disord. 2012 Jun 7;13:91. doi: 10.1186/1471-2474-13-91.
PMID: 22676321BACKGROUNDGhert M, Deheshi B, Holt G, Randall RL, Ferguson P, Wunder J, Turcotte R, Werier J, Clarkson P, Damron T, Benevenia J, Anderson M, Gebhardt M, Isler M, Mottard S, Healey J, Evaniew N, Racano A, Sprague S, Swinton M, Bryant D, Thabane L, Guyatt G, Bhandari M; PARITY Investigators. Prophylactic antibiotic regimens in tumour surgery (PARITY): protocol for a multicentre randomised controlled study. BMJ Open. 2012 Nov 28;2(6):e002197. doi: 10.1136/bmjopen-2012-002197. Print 2012.
PMID: 23194956BACKGROUNDRacano A, Pazionis T, Farrokhyar F, Deheshi B, Ghert M. High infection rate outcomes in long-bone tumor surgery with endoprosthetic reconstruction in adults: a systematic review. Clin Orthop Relat Res. 2013 Jun;471(6):2017-27. doi: 10.1007/s11999-013-2842-9. Epub 2013 Feb 12.
PMID: 23404421BACKGROUNDEvaniew N, Nuttall J, Farrokhyar F, Bhandari M, Ghert M. What are the levels of evidence on which we base decisions for surgical management of lower extremity bone tumors? Clin Orthop Relat Res. 2014 Jan;472(1):8-15. doi: 10.1007/s11999-013-3311-1. Epub 2013 Oct 1.
PMID: 24081669BACKGROUNDProphylactic Antibiotic Regimens in Tumor Surgery (PARITY) Investigators; Ghert M, Schneider P, Guyatt G, Thabane L, Velez R, O'Shea T, Randall RL, Turcotte R, Wilson D, Wunder JS, Baptista AM, Cheng EY, Doung YC, Ferguson PC, Giglio V, Hayden J, Heels-Ansdell D, Khan SA, Sampath Kumar V, McKay P, Miller B, van de Sande M, Zumarraga JP, Bhandari M. Comparison of Prophylactic Intravenous Antibiotic Regimens After Endoprosthetic Reconstruction for Lower Extremity Bone Tumors: A Randomized Clinical Trial. JAMA Oncol. 2022 Mar 1;8(3):345-353. doi: 10.1001/jamaoncol.2021.6628.
PMID: 34989778DERIVEDSchneider P, Heels-Ansdell D, Thabane L, Ghert M; PARITY Investigators. Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): a multi-center randomized controlled study comparing alternative antibiotic regimens in patients undergoing tumor resections with endoprosthetic replacements-a statistical analysis plan. Trials. 2021 Mar 22;22(1):223. doi: 10.1186/s13063-021-05147-2.
PMID: 33752752DERIVEDGazendam A, Bozzo A, Schneider P, Giglio V, Wilson D, Ghert M. Recruitment patterns in a large international randomized controlled trial of perioperative care in cancer patients. Trials. 2021 Mar 20;22(1):219. doi: 10.1186/s13063-021-05149-0.
PMID: 33743753DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Ghert, MD, FRCSC
McMaster University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor | Department of Surgery
Study Record Dates
First Submitted
November 15, 2011
First Posted
November 24, 2011
Study Start
January 1, 2013
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
March 11, 2021
Record last verified: 2021-03