Antibiotics for Preventing Infections After Pancreatic Surgery

Recruiting at 32 trial locations

Overseen By Sepideh Gholami, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Glucocorticosteroids, Antimicrobials

Disqualifiers: Minimally invasive PD, Allergies, Dialysis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

958 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michael D'Angelica, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Adults (18+) scheduled for pancreatoduodenectomy can join this trial. It's not for pregnant/nursing women, those with allergies to penicillins/cephalosporins, patients on long-term steroids or dialysis, anyone with a recent infection or antibiotic use, and those unlikely to need the surgery per their surgeon.

Inclusion Criteria

I am scheduled for a surgery to remove part of my pancreas and small intestine.

Exclusion Criteria

I am having or had a minimally invasive surgery for pancreatic disease.

My kidney function is low, with a creatinine clearance of 40 mL/min or less.

I have an infection or took antibiotics within a week before surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cefoxitin or piperacillin-tazobactam as surgical antibiotic prophylaxis during pancreatoduodenectomy

1 day

Follow-up

Participants are monitored for surgical site infections postoperatively

4 weeks

Treatment Details

Interventions

• Cefoxitin
• Piperacillin-tazobactam

Trial Overview The study is testing whether Cefoxitin or Piperacillin-Tazobactam antibiotics are more effective in preventing infections after pancreatoduodenectomy—a surgical procedure involving the removal of part of the pancreas.

Participant Groups

Group I: Piperacillin-tazobactam Experimental Treatment 1 Intervention

Group II: Cefoxitin Active Control 1 Intervention

Cefoxitin is already approved in United States, European Union for the following indications:

Approved in United States as Mefoxin for:

• Lower respiratory tract infections
• Urinary tract infections
• Skin and skin structure infections
• Bone and joint infections
• Gynecologic infections
• Intra-abdominal infections
• Septicemia

Approved in European Union as Cefoxitin for:

• Infections caused by anaerobic bacteria
• Infections of the urinary tract
• Infections of the lower respiratory tract
• Infections of the skin and soft tissues
• Infections of bones and joints
• Infections of the female genital tract
• Intra-abdominal infections
• Septicaemia

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Stony Brook Medicine

Collaborator

Trials

1

Recruited

960+

Universtiy of Mississippi Medical Center

Collaborator

Trials

1

Recruited

960+

Gundersen Lutheran Medical Center

Collaborator

Trials

1

Recruited

960+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Fox Chase Cancer Center

Collaborator

Trials

236

Recruited

39,300+

North Shore University HealthSystem

Collaborator

Trials

1

Recruited

960+

Brody School of Medicine at East Carolina University

Collaborator

Trials

1

Recruited

960+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+