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Antibiotics for Protecting Gut Bacteria During Stem Cell Transplant

Phase 2

Recruiting

Led By Boglarka Gyurkocza, 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 +/- 2 days after initiation of piperacillin-tazobactam or cefepime

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

measurement of fold-change in Clostridiales abundance

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,438 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

Frequently Asked Questions

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

What are the most common cefepime prescriptions?

"Cefepime is most commonly used to fight septicemia, but it can also be used against febrile neutropenia, urinary tract infection, and other bacterial infections."

Answered by AI

Has cefepime been greenlit by the FDA?

"Cefepime was deemed a 2 in terms of safety. This is because, while there is evidence that suggests it is safe, there is none to support that it is effective."

Answered by AI

Are there any open slots left for participants in this trial?

"That is correct. The clinical trial in question, which was first posted on February 10th 2017 and updated most recently on June 24th 2022, is looking for 288 patients from 2 different locations."

Answered by AI

How many people are participating in this trial?

"That is correct, the information on clinicaltrials.gov does state that this trial is actively looking for participants. According to the website, the first posting was on 2/10/2017 and the most recent edit was on 6/24/2022. They are hoping to enroll 288 patients from 2 different locations."

Answered by AI

Is cefepime a common medication in clinical trials?

"cefepime was first studied in 2016 at Royal Glamorgan Hospital. As of now, 77 trials have been completed while 21 are still ongoing. Many of the active trials are being conducted in New york City."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant

2017. "Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03078010.

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