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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total participant count for this clinical trial?

"Presently, this study is not looking for new participants. It was first posted on November 21st, 2017 and was last edited on August 31st, 2022. If you are hoping to find other studies, 734 clinical trials are actively recruiting patients with pancreatic diseases and 19 studies are enrolling patients that Piperacillin-tazobactam."

Answered by AI

Could you elaborate on other scientific research that has used Piperacillin-tazobactam?

"59 clinical trials have completed studying piperacillin-tazobactam since it was first examined in 2016 at Milton Keynes University Hospital. Out of the 19 trials currently underway, a large proportion are located in Philadelphia, Pennsylvania."

Answered by AI

Are there a large number of facilities conducting this particular clinical trial across the state?

"Some of the hospitals currently running this trial are Thomas Jefferson University Hospital in Philadelphia, Pennsylvania, Ohio State University in Columbus, Ohio, and UC Davis Comprehensive Cancer Center in Sacramento, California - to name a few of the 31 other locations."

Answered by AI

When is Piperacillin-tazobactam typically given to patients?

"Piperacillin-tazobactam is commonly used to fight intraabdominal infections. This medication can also help patients with lower respiratory tract infection (lrti), lung abscess, and bacterial infections."

Answered by AI

Are new participants currently being welcomed into this research?

"According to the website, this clinical trial is not recruiting patients at the moment. The original posting date was November 21st, 2017, and the most recent edit was on August 31st, 2022. There are, however, 753 other trials that are actively recruiting patients."

Answered by AI

If I take Piperacillin-tazobactam, are there any risks I should be aware of?

"We believe that Piperacillin-tazobactam is safe based on the fact that it is a Phase 3 trial, which suggests that there is both efficacy and safety data supporting its use."

Answered by AI
~48 spots leftby Aug 2024