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Cephalosporin

Antibiotics for Preventing Infections After Pancreatic Surgery

Phase 3
Waitlist Available
Led By Michael D'Angelica, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >/= 18 years
Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

This trial will compare two different antibiotics to see which one is better at preventing surgical site infections after pancreatoduodenectomy.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include allergic reactions, gastrointestinal issues like nausea and diarrhea, potential kidney damage especially if there's pre-existing kidney disease, and increased risk of fungal or other non-bacterial infections due to changes in body flora.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am scheduled for a surgery to remove part of my pancreas and small intestine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare the effectiveness of cefoxitin with piperacillin-tazobactam as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative surgical site infections in participants undergoing pancreatoduodenectomy

Side effects data

From 2017 Phase 2 & 3 trial • 465 Patients • NCT02753946
5%
Diarrhea
3%
Infusion site phlebitis
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
2%
Headache
1%
Nausea
1%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Piperacillin Tazobactam
ZTI-01

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Piperacillin-tazobactamExperimental Treatment1 Intervention
Group II: CefoxitinActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Piperacillin-tazobactam
2016
Completed Phase 4
~520

Find a Location

Who is running the clinical trial?

Stony Brook MedicineUNKNOWN
Universtiy of Mississippi Medical CenterUNKNOWN
Gundersen Lutheran Medical CenterUNKNOWN

Media Library

Cefoxitin (Cephalosporin) Clinical Trial Eligibility Overview. Trial Name: NCT03269994 — Phase 3
Pancreatic Cancer Research Study Groups: Piperacillin-tazobactam, Cefoxitin
Pancreatic Cancer Clinical Trial 2023: Cefoxitin Highlights & Side Effects. Trial Name: NCT03269994 — Phase 3
Cefoxitin (Cephalosporin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03269994 — Phase 3
~24 spots leftby Aug 2024
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