Clinical trial · Interventional
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)
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
NCT01479283CI-TRIAL-00050611PARITYcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Neoplasms | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 24-Hour Prophylactic Cefazolin* Antibiotic Regimen | Drug | — | UNRESOLVED |
| 5-Days Prophylactic Cefazolin* Antibiotic Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Short-Arm Antibiotic Regimen
- description
- 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
- interventionNames
- Drug: 24-Hour Prophylactic Cefazolin* Antibiotic Regimen
- type
- EXPERIMENTAL
- label
- Long-Arm Antibiotic Regimen
- description
- 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
- interventionNames
- Drug: 5-Days Prophylactic Cefazolin* Antibiotic Regimen
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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).
References
Publications (7)
- BACKGROUNDHasan 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 22676321
- BACKGROUNDGhert 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 23194956
- BACKGROUNDRacano 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 23404421
- BACKGROUNDEvaniew 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 24081669
- DERIVEDProphylactic 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 34989778
- Schneider 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.