CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 967 enrolled
Drug / intervention
Cefoxitin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03269994
NCT03269994Phase 3Completed
CompareCT.gov

A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy

Memorial Sloan Kettering Cancer Center·interventional·Posted Sep 1, 2017·Updated Oct 21, 2025

In Brief

A Phase 3 clinical trial evaluating Cefoxitin and Piperacillin-tazobactam for Pancreatic Cancer and 2 related conditions. Completed, enrolled 967 participants across 32 sites in 2 countries.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 1, 2017
Enrollment StartNov 21, 2017
Primary CompletionJan 28, 2025
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 8.8 years ago

Interventions

Cefoxitindrug

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.

Piperacillin-tazobactamdrug

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.