Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY)

PHASE3CompletedINTERVENTIONAL
Enrollment

602

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

March 31, 2021

Study Completion Date

March 31, 2021

Conditions
InfectionBone Neoplasms
Interventions
DRUG

24-Hour Prophylactic Cefazolin* Antibiotic Regimen

"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

5-Days Prophylactic Cefazolin* Antibiotic Regimen

"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."

Trial Locations (54)

1629

Hospital Universitario Austral, Pilar

2333

Leiden University Medical Center, Leiden

5000

Royal Adelaide Hospital, Adelaide

10065

Memorial Sloan-Kettering Cancer Center, New York

10467

Montefiore Medical Center, The Bronx

11206

Albany Medical Center, Albany

13057

SUNY Upstate University Hospital, East Syracuse

15213

University of Pittsburgh Medical Center, Pittsburgh

19107

The Rothman Institute at Jefferson, Philadelphia

21201

University of Maryland Medical Center, Baltimore

21215

Sinai Hospital of Baltimore, Baltimore

21237

Franklin Square Medical Center, Baltimore

21287

Johns Hopkins Hospital, Baltimore

30329

Emory Orthopaedics and Spine Center, Atlanta

43210

Wexner Medical Center, Columbus

44195

The Cleveland Clinic - Hillcrest Hospital, Cleveland

45229

Cincinnati Children's Hospital, Cincinnati

52242

Holden Comprehensive Cancer Center, Iowa City

53226

Medical College of Wisconsin - Froedtert Hospital, Milwaukee

55454

University of Minnesota Medical Center, Minneapolis

63110

Saint Louis University Hospital, St Louis

72205

University of Arkansas for Medical Sciences, Little Rock

84112

Huntsman Cancer Institute, Salt Lake City

90404

Ronald Reagan UCLA Medical Center, Los Angeles

94063

Stanford University Hospital and Clinics, Redwood City

94118

University of California San Francisco Medical Center, San Francisco

95817

UC Davis Comprehensive Cancer Center, Sacramento

97239

Oregon Health & Science University Hospital, Portland

06030

University of Connecticut Health Center, Farmington

06106

Hartford Hospital, Hartford

32611-2727

University of Florida Health Shands Hospital, Gainesville

02114

Massachusetts General Hospital, Boston

02115

Boston Children's Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

New York

"Long Island Jewish Medical Center , Northwell Health"

37232-8774

Vanderbilt Medical Center, Nashville

Unknown

LKH - Universitätsklinikum Graz, Graz

Hospital de Clínicas de Porto Alegre, Porto Alegre

Instituto de Ortopedia e Traumatologia, São Paulo

Children's Cancer Hospital Egypt, Cairo

All India Institute of Medical Sciences, New Delhi

University Medical Center Groningen, Groningen

Singapore General Hospital, Singapore

Grey's Hospital, Pietermaritzburg

T2N 5A1

Foothills Medical Centre, Calgary

V5Z 4E6

Vancouver General Hospital, Vancouver

L8V 5C2

Juravinski Hospital and Cancer Centre, Hamilton

K1H 8L6

Ottawa Hospital, Ottawa

M5G 1X5

Mount Sinai Hospital, Toronto

H1T4B3

Maisonneuve-Rosemont Hospital, Montreal

H3G 1A4

McGill University Health Centre, Montreal

G1R 2J6

Hôtel-Dieu de Québec, Québec

08035

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
collaborator

Orthopedic Research and Education Foundation

OTHER

collaborator

The Physicians' Services Incorporated Foundation

OTHER

collaborator

Canadian Cancer Society (CCS)

OTHER

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

lead

McMaster University

OTHER

NCT01479283 - Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) | Biotech Hunter | Biotech Hunter