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Antibiotics for Protecting Gut Bacteria During Stem Cell Transplant

Phase 2
Recruiting
Led By Susan Seo, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 +/- 2 days after initiation of piperacillin-tazobactam or cefepime
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing how different antibiotics effect the good bacteria in the gut. They will be testing patients before and after transplant to see how the antibiotics effect them.

Who is the study for?
Adults with blood cancers undergoing stem cell transplants can join this trial. They must not have been on gut-affecting antibiotics for long periods recently, should not currently have a fever, and their kidneys need to work well. Those allergic to the study drugs or with certain drug-resistant infections cannot participate.
What is being tested?
The trial is testing how two antibiotics, Piperacillin-tazobactam and cefepime, impact the good bacteria in the gut during stem cell transplant recovery. It will involve monitoring changes in these bacteria through urine samples at several points before and after starting antibiotic therapy.
What are the potential side effects?
Possible side effects of both antibiotics include allergic reactions like rash or anaphylaxis, potential harm to kidney function, disruption of normal gut bacteria leading to diarrhea or infection by resistant organisms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 +/- 2 days after initiation of piperacillin-tazobactam or cefepime
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 +/- 2 days after initiation of piperacillin-tazobactam or cefepime for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
measurement of fold-change in Clostridiales abundance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: cefepimeExperimental Treatment1 Intervention
Group II: Piperacillin-tazobactamActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cefepime
2005
Completed Phase 4
~150

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
596,863 Total Patients Enrolled
Susan Seo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
126 Total Patients Enrolled
Boglarka Gyurkocza, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
1,374 Total Patients Enrolled

Media Library

cefepime Clinical Trial Eligibility Overview. Trial Name: NCT03078010 — Phase 2
Febrile Neutropenia Research Study Groups: Piperacillin-tazobactam, cefepime
Febrile Neutropenia Clinical Trial 2023: cefepime Highlights & Side Effects. Trial Name: NCT03078010 — Phase 2
cefepime 2023 Treatment Timeline for Medical Study. Trial Name: NCT03078010 — Phase 2
~10 spots leftby Feb 2025
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