Piperacillin-tazobactam for Pancreatic Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pancreatic Cancer+1 MorePiperacillin-tazobactam - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Pancreatic Cancer
  • Pancreatic Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 30 days

30 days
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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

ZTI-01
9%Alanine aminotransferase increased
7%Aspartate aminotransferase increased
6%Hypokalemia
4%Diarrhea
4%Nausea
4%Vomiting
3%Headache
1%Infusion site phlebitis
This histogram enumerates side effects from a completed 2017 Phase 2 & 3 trial (NCT02753946) in the ZTI-01 ARM group. Side effects include: Alanine aminotransferase increased with 9%, Aspartate aminotransferase increased with 7%, Hypokalemia with 6%, Diarrhea with 4%, Nausea with 4%.

Trial Design

2 Treatment Groups

Cefoxitin
1 of 2
Piperacillin-tazobactam
1 of 2

Active Control

Experimental Treatment

962 Total Participants · 2 Treatment Groups

Primary Treatment: Piperacillin-tazobactam · No Placebo Group · Phase 3

Piperacillin-tazobactam
Drug
Experimental Group · 1 Intervention: Piperacillin-tazobactam · Intervention Types: Drug
Cefoxitin
Drug
ActiveComparator Group · 1 Intervention: Cefoxitin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazobactam
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days

Who is running the clinical trial?

Stony Brook MedicineUNKNOWN
Thomas Jefferson UniversityOTHER
407 Previous Clinical Trials
135,143 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
583,576 Total Patients Enrolled
Intermountain Health Care, Inc.OTHER
133 Previous Clinical Trials
1,789,637 Total Patients Enrolled
Milton S. Hershey Medical CenterOTHER
462 Previous Clinical Trials
2,783,764 Total Patients Enrolled
Gundersen Lutheran Medical CenterUNKNOWN
University of ChicagoOTHER
927 Previous Clinical Trials
753,050 Total Patients Enrolled
Providence Health & ServicesOTHER
107 Previous Clinical Trials
52,413 Total Patients Enrolled
Temple UniversityOTHER
269 Previous Clinical Trials
73,413 Total Patients Enrolled
Sunnybrook Health Sciences Centre, CanadaUNKNOWN
Massachusetts General HospitalOTHER
2,703 Previous Clinical Trials
30,852,246 Total Patients Enrolled
North Shore University HealthSystemUNKNOWN
Montefiore Medical Center/Albert Einstein College of MedicineUNKNOWN
Indiana UniversityOTHER
878 Previous Clinical Trials
759,073 Total Patients Enrolled
Hackensack Meridian HealthOTHER
114 Previous Clinical Trials
23,823 Total Patients Enrolled
Rhode Island HospitalOTHER
239 Previous Clinical Trials
58,352 Total Patients Enrolled
Advocate Illinois Masonic Medical CenterOTHER
The Cleveland ClinicOTHER
951 Previous Clinical Trials
1,408,864 Total Patients Enrolled
Baptist Memorial Health Care CorporationOTHER
5 Previous Clinical Trials
20,789 Total Patients Enrolled
Baylor Scott and White HealthOTHER
12 Previous Clinical Trials
154,703 Total Patients Enrolled
Emory UniversityOTHER
1,509 Previous Clinical Trials
2,705,044 Total Patients Enrolled
Hamilton Health Sciences CenterUNKNOWN
University of Wisconsin, MadisonOTHER
1,070 Previous Clinical Trials
2,575,679 Total Patients Enrolled
Washington University School of MedicineOTHER
1,805 Previous Clinical Trials
2,277,653 Total Patients Enrolled
Fox Chase Cancer CenterOTHER
215 Previous Clinical Trials
32,560 Total Patients Enrolled
Jersey Shore Medical Center (Hackensack Meridian)UNKNOWN
Johns Hopkins UniversityOTHER
2,080 Previous Clinical Trials
31,019,501 Total Patients Enrolled
The Ohio State University Wexner Medical CenterUNKNOWN
University of Texas Southwestern Medical CenterOTHER
953 Previous Clinical Trials
607,730 Total Patients Enrolled
The Ottowa Hospital/University of OttowaUNKNOWN
University of IowaOTHER
410 Previous Clinical Trials
874,967 Total Patients Enrolled
Universtiy of Mississippi Medical CenterUNKNOWN
Brody School of Medicine at East Carolina UniversityUNKNOWN
University of California, DavisOTHER
844 Previous Clinical Trials
5,013,389 Total Patients Enrolled
University of UtahOTHER
1,003 Previous Clinical Trials
1,784,192 Total Patients Enrolled
Albany Medical CollegeOTHER
85 Previous Clinical Trials
9,440 Total Patients Enrolled
Northwestern UniversityOTHER
1,458 Previous Clinical Trials
789,133 Total Patients Enrolled
Mount Sinai Hospital, New YorkOTHER
33 Previous Clinical Trials
1,222,088 Total Patients Enrolled
Michael D'Angelica, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
724 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients undergoing elective PD for any diagnosis/indication.