Infection Clinical Trial
— PARITYOfficial title:
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center International Randomized Controlled Trial Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections With Endoprosthetic Replacements
NCT number | NCT01479283 |
Other study ID # | GHRT01 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | January 2013 |
Est. completion date | March 2021 |
Verified date | March 2021 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 602 |
Est. completion date | March 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Universitario Austral | Pilar | Buenos Aires |
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Austria | LKH - Universitätsklinikum Graz | Graz | |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | |
Brazil | Instituto de Ortopedia e Traumatologia | São Paulo | |
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Juravinski Hospital and Cancer Centre | Hamilton | Ontario |
Canada | Maisonneuve-Rosemont Hospital | Montreal | Quebec |
Canada | McGill University Health Centre | Montreal | Quebec |
Canada | Ottawa Hospital | Ottawa | Ontario |
Canada | Hôtel-Dieu de Québec | Québec City | Quebec |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Egypt | Children's Cancer Hospital Egypt | Cairo | |
India | All India Institute of Medical Sciences | New Delhi | Delhi |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Leiden University Medical Center | Leiden | South Holland |
Singapore | Singapore General Hospital | Singapore | |
South Africa | Grey's Hospital | Pietermaritzburg | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
United States | Albany Medical Center | Albany | New York |
United States | Emory Orthopaedics and Spine Center | Atlanta | Georgia |
United States | Franklin Square Medical Center | Baltimore | Maryland |
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
United States | The Cleveland Clinic - Hillcrest Hospital | Cleveland | Ohio |
United States | Wexner Medical Center | Columbus | Ohio |
United States | SUNY Upstate University Hospital | East Syracuse | New York |
United States | University of Connecticut Health Center | Farmington | Connecticut |
United States | University of Florida Health Shands Hospital | Gainesville | Florida |
United States | Hartford Hospital | Hartford | Connecticut |
United States | Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
United States | Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin |
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
United States | Vanderbilt Medical Center | Nashville | Tennessee |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | The Rothman Institute at Jefferson | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University Hospital | Portland | Oregon |
United States | Long Island Jewish Medical Center | Northwell Health | Queens | New York |
United States | Stanford University Hospital and Clinics | Redwood City | California |
United States | UC Davis Comprehensive Cancer Center | Sacramento | California |
United States | Saint Louis University Hospital | Saint Louis | Missouri |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | University of California San Francisco Medical Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), Orthopedic Research and Education Foundation, The Physicians' Services Incorporated Foundation |
United States, Argentina, Australia, Austria, Brazil, Canada, Egypt, India, Netherlands, Singapore, South Africa, Spain,
Evaniew 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. Review. — View Citation
Ghert 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). pii: e002197. doi: 10.1136/bmjopen-2012-002197. Print 2012. — View Citation
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. — View Citation
Racano 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Functional Outcome and Quality of Life | as measured by the Musculoskeletal Tumor Society (MSTS) functional score (1987 and 1993 versions) and the Toronto Extremity Salvage Score (TESS) questionnaires | 1 year | |
Secondary | Antibiotic-Related Complications | examples of antibiotic-related complications include gastrointestinal infections, fungal infections, etc. | 1 year | |
Secondary | Rate of Re-Operation | re-operation may be required if patients develop a surgical site infection | 1 year | |
Secondary | Oncologic Recurrence and/or Metastases | 1 year | ||
Secondary | Mortality | 1 year |
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