A Phase 3 interventional study of Cefoxitin and Piperacillin-tazobactam in Pancreatic Cancer, Pancreas Cancer and Pancreatic Diseases, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 32 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-21.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: Cefoxitin
Drug: Piperacillin-tazobactam
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.
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.
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.
Time frame: 30 days
| Milestone | Cefoxitin | Piperacillin-tazobactam |
|---|---|---|
| Started | 484 | 483 |
| Completed | 400 | 378 |
| Not completed | 84 | 105 |
| Withdrew: Withdrawal by subject | 4 | 5 |
| Withdrew: Unresectable at surgery | 39 | 58 |
| Withdrew: Patient canceled surgery | 5 | 14 |
| Withdrew: Preoperative progression | 14 | 9 |
| Withdrew: Preoperative infection | 10 | 4 |
| Withdrew: Kidney insufficiency | 1 | 0 |
| Withdrew: Drug allergy | 0 | 2 |
| Withdrew: Operation changed to different resection | 9 | 0 |
| Withdrew: Preoperative steroid | 0 | 3 |
| Withdrew: Accrual closed | 2 | 0 |
| Withdrew: Operation changed to different resection | 0 | 10 |
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.
| Participants | Cefoxitin | Piperacillin-tazobactam |
|---|---|---|
| Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. | 400 | 378 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cefoxitin | 10/400 (2.5%) | 10/400 (2.5%) | 0/400 (0%) |
| Piperacillin-tazobactam | 5/378 (1.3%) | 5/378 (1.3%) | 0/378 (0%) |
| Event | Cefoxitin | Piperacillin-tazobactam |
|---|---|---|
| DeathGeneral disorders | 10/400 | 5/378 |
| Age, Continuous(years) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| Median | 68.0 (59.8 to 73.9) | 66.8 (59.6 to 73.8) | 67.0 (59.6 to 73.9) |
| Sex: Female, Male(Participants) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| Female | 177 | 145 | 322 |
| Male | 223 | 233 | 456 |
| Ethnicity (NIH/OMB)(Participants) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 6 | 12 |
| Not Hispanic or Latino | 307 | 280 | 587 |
| Unknown or Not Reported | 87 | 92 | 179 |
| Race (NIH/OMB)(Participants) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 4 | 8 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 27 | 19 | 46 |
| White | 276 | 258 | 534 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 93 | 92 | 185 |
| Region of Enrollment(Participants) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| United States | 400 | 378 | 778 |
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Memorial Sloan Kettering Cancer Center