Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?

NCT03269994 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 17-418
• Study Type: interventional
• Target: 967
• Locations: 2 countries
• Sites: 32

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.

Conditions

Pancreatic Cancer; Pancreas Cancer; Pancreatic Diseases

Keywords

pancreatoduodenectomy; 17-418; cefoxitin; piperacillin-tazobactam

Outcome Measures

Primary Outcomes (1)

• Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.

  To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.

  30 days

Study Arms (2)

Cefoxitin

ACTIVE COMPARATOR

Drug: Cefoxitin

Piperacillin-tazobactam

EXPERIMENTAL

Drug: Piperacillin-tazobactam

Interventions

Cefoxitin DRUG

Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.

Cefoxitin

Piperacillin-tazobactam DRUG

Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.

Piperacillin-tazobactam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Indiana University: collaborator
• Massachusetts General Hospital: collaborator
• Thomas Jefferson University: collaborator
• Washington University School of Medicine: collaborator
• Advocate Illinois Masonic Medical Center: collaborator
• Baptist Memorial Health Care Corporation: collaborator
• Baylor Scott and White Health: collaborator
• The Cleveland Clinic: collaborator
• Emory University: collaborator
• Fox Chase Cancer Center: collaborator
• Gundersen Lutheran Medical Center: collaborator
• Hackensack Meridian Health: collaborator
• Hamilton Health Sciences Center: collaborator
• Intermountain Health Care, Inc.: collaborator
• Jersey Shore Medical Center (Hackensack Meridian): collaborator
• Johns Hopkins University: collaborator
• Montefiore Medical Center/Albert Einstein College of Medicine: collaborator
• North Shore University HealthSystem: collaborator
• Milton S. Hershey Medical Center: collaborator
• Rhode Island Hospital: collaborator
• Stony Brook Medicine: collaborator
• Sunnybrook Health Sciences Centre, Canada: collaborator
• Temple University: collaborator
• Ohio State University: collaborator
• The Ottowa Hospital/University of Ottowa: collaborator
• University of California, Davis: collaborator
• University of Chicago: collaborator
• University of Iowa: collaborator
• University of Texas Southwestern Medical Center: collaborator
• University of Utah: collaborator
• University of Wisconsin, Madison: collaborator
• Providence Health & Services: collaborator
• Albany Medical College: collaborator
• Northwestern University: collaborator
• Universtiy of Mississippi Medical Center: collaborator
• Mount Sinai Hospital, New York: collaborator
• Brody School of Medicine at East Carolina University: collaborator

Study Sites (32)

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Northwestern Medicine (Data Collection)

Chicago, Illinois, 60611, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Washington School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Memorial Sloan Kettering Basking Ridge (Consent only)

Basking Ridge, New Jersey, 07920, United States

Location

Hackensack Meridian Health / Hackensack University Medical Center Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, 11725, United States

Location

Memoral Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Mount Sinai West

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Health Systems (Montefiore Medical Center)

The Bronx, New York, 10467, United States

Location

Duke University

Durham, North Carolina, 27713, United States

Location

Brody School of Medicine at East Carolina University

Greenville, North Carolina, 27834, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Providence Health & Services (Portland Med Ctr)

Portland, Oregon, 97213, United States

Location

Pennsylvania State Hershey

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Baptist Memorial Healthcare

Memphis, Tennessee, 38120, United States

Location

Baylor Scott & White Health

Dallas, Texas, 75246, United States

Location

Intermountain Healthcare

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Gundersen Lutheran Medical Foundation

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Hamilton Health Sciences Center (Juravinski Hospital)

Hamilton, Ontario, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (2)

• D'Angelica MI, Ellis RJ, Liu JB, Brajcich BC, Gonen M, Thompson VM, Cohen ME, Seo SK, Zabor EC, Babicky ML, Bentrem DJ, Behrman SW, Bertens KA, Celinski SA, Chan CHF, Dillhoff M, Dixon MEB, Fernandez-Del Castillo C, Gholami S, House MG, Karanicolas PJ, Lavu H, Maithel SK, McAuliffe JC, Ott MJ, Reames BN, Sanford DE, Sarpel U, Scaife CL, Serrano PE, Smith T, Snyder RA, Talamonti MS, Weber SM, Yopp AC, Pitt HA, Ko CY. Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1579-1588. doi: 10.1001/jama.2023.5728.

  PMID: 37078771 DERIVED

• 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.

  PMID: 33664081 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Diseases

Interventions

Cefoxitin; Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cephamycins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Penicillins; Piperacillin; Ampicillin; Penicillin G; Sulfones; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Michael D'Angelica, MD
• Organization: Memorial Sloan Kettering Cancer Center

dangelim@mskcc.org

212-639-3226

Study Officials

• Michael D'Angelica, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: November 21, 2017
• Primary Completion: January 28, 2025
• Study Completion: January 28, 2025
• Last Updated: October 21, 2025
• Results First Posted: October 21, 2025

Record last verified: 2025-01

Locations

US (29); CA (3)