Antibiotics for Protecting Gut Bacteria During Stem Cell Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different antibiotics, cefepime and piperacillin-tazobactam, affect the beneficial bacteria in the gut during stem cell transplants. These bacteria aid digestion and overall health, and their loss can lead to infections and other complications. The study aims to determine which antibiotic better protects these helpful organisms. Individuals with any blood cancer, such as leukemia or lymphoma, undergoing a stem cell transplant might be suitable participants, especially if they do not have severe allergies to the study antibiotics. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on prolonged antibiotic treatment for an ongoing infection, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both Cefepime and Piperacillin-tazobactam are generally safe for stem cell transplant patients, but certain considerations are important.
Cefepime effectively prevents infections in these patients, who often have weakened immune systems. While Cefepime manages this risk, monitoring for side effects, such as allergic reactions or changes in blood cell counts, is crucial.
Research also supports Piperacillin-tazobactam as an effective antibiotic for preventing infections after stem cell transplants. It is usually well-tolerated, but mild side effects like nausea or diarrhea may occur. Caution is necessary for allergic reactions, especially in those with a history of penicillin allergies.
Both antibiotics prevent infections during the vulnerable period after a stem cell transplant. Although considered safe and generally well-tolerated, patients require close monitoring for any adverse reactions.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they explore new ways to protect gut bacteria during stem cell transplants. Unlike standard antibiotics, which can indiscriminately wipe out gut bacteria, cefepime is being studied for its potential to be less disruptive to the gut microbiome. Additionally, piperacillin-tazobactam is being compared as an active comparator to see if it offers better protection for gut health during these transplants. These treatments could lead to better outcomes by maintaining a healthier balance of gut bacteria, which is crucial for recovery and overall health after transplantation.
What evidence suggests that this trial's antibiotics could be effective for protecting gut bacteria during stem cell transplant?
This trial will compare the effects of two antibiotics, cefepime and piperacillin-tazobactam, on gut bacteria during stem cell transplants. Studies have shown that antibiotics can affect helpful gut bacteria, especially during such procedures. Research indicates that cefepime can reduce the variety of gut bacteria, potentially increasing the risk of infections or graft-versus-host disease (GVHD). Piperacillin-tazobactam, another antibiotic in this trial, is known to cause significant changes in gut bacteria. Both antibiotics can impact the gut microbiome, affecting outcomes like GVHD after transplants. These changes in gut bacteria are crucial because they can influence recovery and overall health during and after the stem cell transplant process.678910
Who Is on the Research Team?
Susan Seo, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either piperacillin-tazobactam or cefepime to assess the impact on gut bacteria
Follow-up
Participants are monitored for changes in gut microbiota and safety post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cefepime
- Piperacillin-tazobactam
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor