Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Keywords

Pancreatic Cancer Pancreas Cancer Pancreatic Diseases pancreatoduodenectomy 17-418 cefoxitin piperacillin-tazobactam Pancreatic Neoplasms Tazobactam Piperacillin Piperacillin, Tazobactam Drug Combination Cefotaxime

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join 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

Locations

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Providence Health & Services (Portland Med Ctr) accepting new patients
    Portland Oregon 97213 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Memorial Sloan Kettering Cancer Center
Links
Memorial Sloan Kettering Cancer Center
Sign up for this study
ID
NCT03269994
Phase
Phase 3
Study Type
Interventional
Last Updated