Antibiotics for Preventing Infections After Pancreatic Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether cefoxitin or piperacillin-tazobactam better prevents infections after pancreatic surgery. It specifically focuses on individuals undergoing a pancreatoduodenectomy, a type of pancreatic surgery. Participants planning to undergo this surgery and without allergies to certain antibiotics might be suitable candidates. The trial compares the effectiveness of these two antibiotics in reducing surgical site infections. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on long-term glucocorticosteroids or have taken antibiotics within 7 days before surgery, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both cefoxitin and piperacillin-tazobactam are antibiotics under study for their safety and effectiveness in preventing infections after pancreatic surgery.
For piperacillin-tazobactam, studies have found it can significantly reduce infections at the surgery site compared to other treatments. One study noted that patients receiving piperacillin-tazobactam had fewer infections, cutting the risk by more than half in some cases. This suggests it is well-tolerated and has a good safety record for preventing infections after surgery.
Cefoxitin, although not as detailed in the sources, is often used in similar surgeries and is considered safe. The trial's later stage indicates that both antibiotics have undergone sufficient testing to suggest safety.
Participants considering this trial can feel reassured knowing that previous research has found both treatments safe, and they are being compared to determine the best option for reducing infections after surgery.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Piperacillin-tazobactam and Cefoxitin as potential options to prevent infections after pancreatic surgery. Unlike traditional antibiotics used post-surgery, Piperacillin-tazobactam offers broad-spectrum coverage, which means it can target a wider range of bacteria, including those resistant to other drugs. Cefoxitin, on the other hand, is known for its ability to combat specific bacteria that are common culprits in surgical infections. These features could lead to more effective infection prevention, reducing complications and improving recovery times for patients.
What evidence suggests that this trial's treatments could be effective for preventing infections after pancreatic surgery?
This trial compares piperacillin-tazobactam and cefoxitin to determine which more effectively prevents infections after pancreatic surgery. Research has shown that piperacillin-tazobactam, which participants may receive, can significantly reduce surgical site infections, with some studies reporting nearly a 57% reduction in infection rates. This makes it a strong candidate for preventing infections after pancreatic surgeries like pancreatoduodenectomy.
Cefoxitin, another treatment option in this trial, is used to prevent infections, particularly against specific bacteria. While research continues, it is known to be effective against anaerobic bacteria and some gram-negative bacteria, which often cause infections. The trial aims to identify the most effective option for patients undergoing this procedure.678910Who Is on the Research Team?
Michael D'Angelica, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either cefoxitin or piperacillin-tazobactam as surgical antibiotic prophylaxis during pancreatoduodenectomy
Follow-up
Participants are monitored for surgical site infections postoperatively
What Are the Treatments Tested in This Trial?
Interventions
- Cefoxitin
- Piperacillin-tazobactam
Cefoxitin is already approved in United States, European Union for the following indications:
- Lower respiratory tract infections
- Urinary tract infections
- Skin and skin structure infections
- Bone and joint infections
- Gynecologic infections
- Intra-abdominal infections
- Septicemia
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Stony Brook Medicine
Collaborator
Universtiy of Mississippi Medical Center
Collaborator
Gundersen Lutheran Medical Center
Collaborator
Washington University School of Medicine
Collaborator
Fox Chase Cancer Center
Collaborator
North Shore University HealthSystem
Collaborator
Brody School of Medicine at East Carolina University
Collaborator
Massachusetts General Hospital
Collaborator
Ohio State University
Collaborator