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

Status
Active
Cancer Type
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03269994
Protocol IDs
17-418 (primary)
NCI-2017-01743
Study Sponsor
Memorial Sloan Kettering Cancer Center

Summary

This randomized phase III trial studies cefoxitin compared with piperacillin-tazobactam in preventing surgical site infections in patients undergoing pancreatoduodenectomy. Antibiotics, such as cefoxitin and piperacillin-tazobactam, may prevent or control infections in patients undergoing surgery. Giving cefoxitin or piperacillin-tazobactam to find out which antibiotic is better may help patients avoid surgical site infections after their pancreatoduodenectomy, avoid delays in recovery, and minimize extra burdens placed on patients, their families and caregivers.

Objectives

PRIMARY OBJECTIVES:
I. 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 surgical site infections (SSIs) in patients undergoing pancreatoduodenectomy (PD).

SECONDARY OBJECTIVES:
I. To measure and compare the occurrences of non-SSI morbidity and healthcare utilization occurring in patients given a second generation cephalosporin as surgical antibiotic prophylaxis (Cohort 1) versus a broad-spectrum penicillin (Cohort 2).

TERTIARY OBJECTIVES:
I. To determine the bacterial isolates and sensitivities of SSIs that occur in patients in both cohorts.
II. To determine the bacterial isolates and sensitivities of intraoperative bile cultures obtained from patients in both cohorts.

OUTLINE: Patients are randomized to 1 of 2 cohorts.

COHORT A: Patients receive cefoxitin intravenously (IV) once within 1 hour prior to PD incision, every 2-4 hours until closure of incision, and discontinued within 24 hours after anesthesia end time.

COHORT B: Patients receive piperacillin-tazobactam IV once within 1 hour prior to PD incision, every 2-4 hours until closure of incision, and discontinued within 24 hours after anesthesia end time.

After completion of study treatment, patients are followed for 30 days.

Treatment Sites in Georgia

Emory University School of Medicine


1440 Clifton Road
Atlanta, GA 30322


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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