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NCT03078010 · ClinicalTrials.gov registry record · Phase 2
Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant
A Phase 2 study of Febrile Neutropenia and Intestinal Microbiome, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 347
- Enrollment target
- 2
- Study locations
NCT03078010: Active Phase 2 study of Febrile Neutropenia and Intestinal Microbiome, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03078010 is a Phase 2 study of Febrile Neutropenia and Intestinal Microbiome that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 347 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (161% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078010, a Phase 2 study of Febrile Neutropenia and Intestinal Microbiome, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 347 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
Fold change will be assessed 7 +/- 2 days after initiating antibiotic treatment for febrile neutropenia and will be compared to the pre-treatment specimen. Pre-treatment stool specimen will be collected between the time of enrollment Patients will be enrolled and infusion of allografts or first episode of neutropenic fever, whichever occurs first.
Conditions Studied
Interventions
- DRUG Piperacillin-tazobactam
- DRUG cefepime
Study Locations (2)
New Jersey
- Hackensack Meridian Health - Hackensack
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2017-02-10 |
| Est. Completion | 2027-02 |
| Phase | Phase 2 |
What the registry record for NCT03078010 still lists
NCT03078010 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (161% higher).
The record links to 2 conditions, with Febrile Neutropenia appearing as the primary indexed condition, and to 2 interventions - of which Piperacillin-tazobactam is the first listed.
NCT03078010 reports a single indexed study location in New Jersey, New York.
Frequently Asked Questions
What is clinical trial NCT03078010 about?
NCT03078010 is a clinical study titled "Choosing the Best Antibiotic to Protect Friendly Gut Bacteria During the Course of Stem Cell Transplant". 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 ab...
What is the current status of trial NCT03078010?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 347 participants. The study started on 2017-02-10. Estimated completion is 2027-02.
What conditions does trial NCT03078010 study?
This clinical trial studies the following conditions: Febrile Neutropenia, Intestinal Microbiome.
What interventions are being tested in trial NCT03078010?
The interventions under investigation include: Piperacillin-tazobactam (DRUG), cefepime (DRUG).
Who is sponsoring clinical trial NCT03078010?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03078010 being conducted?
This trial has 2 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03078010's enrollment target sits among peer trials
347 136th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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