Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Tran… (NCT03078010) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant
United States347 participantsStarted 2017-02-10
Plain-language summary
The purpose of this study is to see how different antibiotics affect the community of friendly bacteria existing in the intestinal tract (gut). Under normal circumstances, these friendly bacteria are not harmful and they help with normal bodily functions such as digestion. When these bacteria are absent, several complications may occur, such as infections with harmful bacteria or other inflammatory reactions, that can complicate the stem cell transplant course. Treatment with antibiotics or chemotherapy is known to kill off these friendly bacteria. In this study we compare the effects of different antibiotics on the community of friendly bacteria in the gut. For microbiota-related biomarker analysis, optional urine samples (MSKCC patients only) will be collected at baseline, 7 +/-2 days after initiation of antibiotic therapy, and on post-transplant days +28, +56 and +100 (+/- 7days).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Patients with any hematologic malignancy undergoing
Exclusion Criteria:
* Patients with severe allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin. Severe reactions include anaphylaxis and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).
* Patients with unconfirmed allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin can be evaluated by an Allergy/Immunology specialist, after which they may become eligible by a consensus of the treating physician, trial investigator and and the Allery
* Prolonged antibiotic treatment ( ≥10 days, within 3 weeks of enrollment) as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing anti anaerobic antibiotics
* Patients with history of infection with extended-spectrum beta-lactamase producing organism. Patients known to be colonized with multi-drug resistant gram-negative organisms or with history of infection with multi-drug resistant organisms will be evaluated case by case and discussed with infectious disease specialist before enrollment
* Febrile patients
* Patients with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
measurement of fold-change in Clostridiales abundance
Timeframe: 7 +/- 2 days after initiation of piperacillin-tazobactam or cefepime