Clinical trial NCT03269994: Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
Official title: A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Pancreas Cancer
Pancreatic Diseases
Keywords: pancreatoduodenectomy
17-418
cefoxitin
piperacillin-tazobactam
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Massachusetts General Hospital
name: Thomas Jefferson University
name: Washington University School of Medicine
name: Advocate Illinois Masonic Medical Center
name: Baptist Memorial Health Care Corporation
name: Baylor Scott and White Health
name: The Cleveland Clinic
name: Emory University
name: Fox Chase Cancer Center
name: Gundersen Lutheran Medical Center
name: Hackensack Meridian Health
name: Hamilton Health Sciences Center
name: Intermountain Health Care, Inc.
name: Jersey Shore Medical Center (Hackensack Meridian)
name: Johns Hopkins University
name: Montefiore Medical Center/Albert Einstein College of Medicine
name: North Shore University HealthSystem
name: Milton S. Hershey Medical Center
name: Rhode Island Hospital
name: Stony Brook Medicine
name: Sunnybrook Health Sciences Centre, Canada
name: Temple University
name: Ohio State University
name: The Ottowa Hospital/University of Ottowa
name: University of California, Davis
name: University of Chicago
name: University of Iowa
name: University of Texas Southwestern Medical Center
name: University of Utah
name: University of Wisconsin, Madison
name: Providence Health & Services
name: Albany Medical College
name: Northwestern University
name: Universtiy of Mississippi Medical Center
name: Mount Sinai Hospital, New York
name: Brody School of Medicine at East Carolina University
First posted: 2017-09-01
Enrollment: 958
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.


Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years
* Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication

Exclusion Criteria:

* Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
* Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
* Patients who are otherwise ineligible to receive the antibiotics in this study
* Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc.
* Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
* Patients unable to provide informed consent
* Creatinine clearance (CrCl) \</= 40 mL/min
* Patients receiving hemodialysis or peritoneal dialysis
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
* Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery

Primary outcomes:
measure: Compare the effectiveness of cefoxitin with piperacillin-tazobactam as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative surgical site infections in participants undergoing pancreatoduodenectomy
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine (Data Collection)
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: University of Washington School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack Meridian Health / Hackensack University Medical Center Cancer Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Health Systems (Montefiore Medical Center)
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memoral Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: Brody School of Medicine at East Carolina University
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Providence Health & Services (Portland Med Ctr)
state: Oregon
city: Hershey
country: United States
facility: Pennsylvania State Hershey
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Healthcare
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Health
state: Texas
city: Murray
country: United States
facility: Intermountain Healthcare
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Foundation
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Center (Juravinski Hospital)
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael D'Angelica, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nevarez NM, Brajcich BC, Liu J, Ellis R, Ko CY, Pitt HA, D'Angelica MI, Yopp AC. Cefoxitin versus piperacillin-tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 4;11(3):e048398. doi: 10.1136/bmjopen-2020-048398.