drugset / Trial / NCT03269994
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
Phase 3
Completed
967 enrolled
Memorial Sloan Kettering Cancer Center
Advocate Illinois Masonic Medical Center · collabAlbany Medical College · collabBaptist Memorial Health Care Corporation · collabBaylor Scott and White Health · collabBrody School of Medicine at East Carolina University · collabEmory University · collabFox Chase Cancer Center · collabGundersen Lutheran Medical Center · collabHackensack Meridian Health · collabHamilton Health Sciences Center · collabIndiana University · collabIntermountain Health Care, Inc. · collabJersey Shore Medical Center (Hackensack Meridian) · collabJohns Hopkins University · collabMassachusetts General Hospital · collabMilton S. Hershey Medical Center · collabMontefiore Medical Center/Albert Einstein College of Medicine · collabMount Sinai Hospital, New York · collabNorth Shore University HealthSystem · collabNorthwestern University · collabOhio State University · collabProvidence Health & Services · collabRhode Island Hospital · collabStony Brook Medicine · collabSunnybrook Health Sciences Centre · collabTemple University · collabThe Cleveland Clinic · collabThe Ottowa Hospital/University of Ottowa · collabThomas Jefferson University · collabUniversity of California, Davis · collabUniversity of Chicago · collabUniversity of Iowa · collabUniversity of Texas Southwestern Medical Center · collabUniversity of Utah · collabUniversity of Wisconsin, Madison · collabUniverstiy of Mississippi Medical Center · collabWashington University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-11-21
- Primary completion
- 2025-01-28
- Completion
- 2025-01-28
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 3.375 g | Intravenous |
| Subject | Amoxicillin | Other / unclassified | 4 g | Intravenous |
| Comparator | Cefoxitin | Small molecule | 2 g | Intravenous |