InfectionPhase 3PARITYNCT01479283
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
A Phase 3 study testing 24-Hour Prophylactic Cefazolin* Antibiotic Regimen and 5-Days Prophylactic Cefazolin* Antibiotic Regimen in people with Infection and Bone Neoplasms, run by McMaster University at 54 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Infection, Bone Neoplasms
- What is being tested?
- 24-Hour Prophylactic Cefazolin* Antibiotic Regimen and 5-Days Prophylactic Cefazolin* Antibiotic Regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 54 sitesin 12 countries
- Study dates
- Jan 2013to Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 10Show fewer
- 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).
Trial locations and contacts
54 sites in 12 countries.
54 sites in 12 countries
United States34 sites
Albany Medical Center
Albany, New York, 11206
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
University of Maryland Medical Center
Baltimore, Maryland, 21201
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Franklin Square Medical Center
Baltimore, Maryland, 21237
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
The Cleveland Clinic - Hillcrest Hospital
Cleveland, Ohio, 44195
Wexner Medical Center
Columbus, Ohio, 43210
SUNY Upstate University Hospital
East Syracuse, New York, 13057
University of Connecticut Health Center
Farmington, Connecticut, 06030
University of Florida Health Shands Hospital
Gainesville, Florida, 32611-2727
Hartford Hospital
Hartford, Connecticut, 06106
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90404
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
Vanderbilt Medical Center
Nashville, Tennessee, 37232-8774
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
The Rothman Institute at Jefferson
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University Hospital
Portland, Oregon, 97239
Long Island Jewish Medical Center | Northwell Health
Queens, New York, 11040
Stanford University Hospital and Clinics
Redwood City, California, 94063
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of California San Francisco Medical Center
San Francisco, California, 94118
Saint Louis University Hospital
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
Canada8 sites
Foothills Medical Centre
Calgary, Alberta, T2N 5A1
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, L8V 5C2
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T4B3
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E6
Brazil2 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre
Instituto de Ortopedia e Traumatologia
São Paulo
Netherlands2 sites
University Medical Center Groningen
Groningen
Leiden University Medical Center
Leiden, South Holland, 2333
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi
About this study
Official 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
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.
Read the detailed description
Long-bone sarcomas were historically managed with amputation. In the current era of osteosarcoma management, amputations are generally avoided by complex surgeries in which the malignancy is removed and the limb is reconstructed with advanced surgical techniques. This process of limb salvage is possible with improvements in chemotherapeutic regimens, advanced imaging techniques and surgical innovations such as modular metallic implants. However, the risk for surgical complications is high due to the complexity of the surgeries themselves. The most common and devastating complication is a surgical site infection. Background work and data from our pilot study indicates that infection rates approach 15%. Multiple surgical attempts at eradication of the infection fail in 50% of these cases, resulting in amputation. Published guidelines for post-operative antibiotic prophylaxis following many standard and less complex elective surgical procedures dictate that prophylactic antibiotics be discontinued after 24 hours. However, the most effective duration of treatment in sarcoma surgery has not previously been examined. Given the limitations of the evidence, it has not been possible for orthopaedic oncologists to draw firm conclusions and, therefore, clinical practice is highly varied, particularly with respect to antibiotic duration. Our international, multi-center randomized controlled trial will determine whether a 5-day regimen of post-operative prophylactic antibiotics in comparison to a standard 24-hour regimen decreases the rate of surgical site infections after limb salvage surgery within 1-year follow-up.
- Conditions
- Infection, Bone Neoplasms
- Being tested
- 24-Hour Prophylactic Cefazolin* Antibiotic Regimen, 5-Days Prophylactic Cefazolin* Antibiotic Regimen
- Keywords
- Infection, Bone Neoplasms, Prosthesis, Anti-Bacterial Agents, Randomized
- Medical subject headings
- Infections, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-Hour Prophylactic Cefazolin* Antibiotic RegimenDrug
Also called ANCEF ®
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.
5-Days Prophylactic Cefazolin* Antibiotic RegimenDrug
Also called ANCEF ®
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.
| Study group | Role | What they receive |
|---|---|---|
| Short-Arm Antibiotic Regimen | Active comparator | Intervention: 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 Receives: Drug: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen |
| Long-Arm Antibiotic Regimen | Experimental | Intervention: 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 Receives: Drug: 5-Days Prophylactic Cefazolin* Antibiotic Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infections
the development of a surgical site infection according to the criteria established by the Center for Disease Control (CDC)
Measured: 1 year
Secondary outcomes (5)
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
Measured: 1 year
Antibiotic-Related Complications
examples of antibiotic-related complications include gastrointestinal infections, fungal infections, etc.
Measured: 1 year
Rate of Re-Operation
re-operation may be required if patients develop a surgical site infection
Measured: 1 year
Oncologic Recurrence and/or Metastases
Measured: 1 year
Mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startJan 2013
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, The Physicians' Services Incorporated Foundation, Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Michelle Ghert, MD, FRCSC, McMaster University
- Investigators
- Michelle Ghert, MD, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479283
- Sponsor's protocol ID
- GHRT01
- Acronym
- PARITY
- Status last verified
- Mar 2021
- First submitted
- 15 Nov 2011
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 22676321Ghert 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.
PubMed 23194956Racano 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.
PubMed 23404421Evaniew 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.
PubMed 24081669Prophylactic 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.
PubMed 34989778Schneider 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.
PubMed 33752752Gazendam 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.
PubMed 33743753
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01479283
- Acronym / sponsor ID
- PARITY / GHRT01
- Conditions
- Infection, Bone Neoplasms
- Keywords
- Infection, Bone Neoplasms, Prosthesis, Anti-Bacterial Agents, Randomized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, The Physicians' Services Incorporated Foundation, Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2013 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 24 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Long-bone sarcomas were historically managed with amputation. In the current era of osteosarcoma management, amputations are generally avoided by complex surgeries in which the malignancy is removed and the limb is reconstructed with advanced surgical techniques. This process of limb salvage is possible with improvements in chemotherapeutic regimens, advanced imaging techniques and surgical innovations such as modular metallic implants. However, the risk for surgical complications is high due to the complexity of the surgeries themselves. The most common and devastating complication is a surgical site infection. Background work and data from our pilot study indicates that infection rates approach 15%. Multiple surgical attempts at eradication of the infection fail in 50% of these cases, resulting in amputation. Published guidelines for post-operative antibiotic prophylaxis following many standard and less complex elective surgical procedures dictate that prophylactic antibiotics be discontinued after 24 hours. However, the most effective duration of treatment in sarcoma surgery has not previously been examined. Given the limitations of the evidence, it has not been possible for orthopaedic oncologists to draw firm conclusions and, therefore, clinical practice is highly varied, particularly with respect to antibiotic duration. Our international, multi-center randomized controlled trial will determine whether a 5-day regimen of post-operative prophylactic antibiotics in comparison to a standard 24-hour regimen decreases the rate of surgical site infections after limb salvage surgery within 1-year follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-Arm Antibiotic Regimen | Active comparator | Drug: 24-Hour Prophylactic Cefazolin* Antibiotic RegimenIntervention: 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 | Experimental | Drug: 5-Days Prophylactic Cefazolin* Antibiotic RegimenIntervention: 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-Hour Prophylactic Cefazolin* Antibiotic RegimenAlso: ANCEF ®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. | Drug | Short-Arm Antibiotic Regimen |
| 5-Days Prophylactic Cefazolin* Antibiotic RegimenAlso: ANCEF ®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. | Drug | Long-Arm Antibiotic Regimen |
Primary outcome
Surgical Site Infections
Time frame: 1 year
the development of a surgical site infection according to the criteria established by the Center for Disease Control (CDC)
5 secondary outcomes
Functional Outcome and Quality of Life
Time frame: 1 year
Antibiotic-Related Complications
Time frame: 1 year
Rate of Re-Operation
Time frame: 1 year
Oncologic Recurrence and/or Metastases
Time frame: 1 year
Mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 22676321Hasan 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.
- Background: PubMed 23194956Ghert 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.
- Background: PubMed 23404421Racano 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.
- Background: PubMed 24081669Evaniew 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.
- Derived from this study: PubMed 34989778Prophylactic 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.
- Derived from this study: PubMed 33752752Schneider 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.
- Derived from this study: PubMed 33743753Gazendam 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Ghert, MD, FRCSC principal investigator
McMaster University
54 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 24-Hour Prophylactic Cefazolin* Antibiotic Regimen and 5-Days Prophylactic Cefazolin* Antibiotic Regimen in people with Infection and Bone Neoplasms, run by McMaster University at 54 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada, Brazil, Netherlands, Argentina and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infections (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01479283, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.