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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
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,432 Total Patients Enrolled
Boglarka Gyurkocza, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
1,374 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have a fever.My kidney function is low, with an eGFR under 30.I have been on strong antibiotics for more than 10 days recently to prevent or treat an infection.I am 18 years old or older.I am undergoing treatment for a blood cancer.I have severe allergies to certain antibiotics.I have had infections resistant to multiple drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Piperacillin-tazobactam
- Group 2: cefepime
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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