Choosing the Best Antibiotic to Protect Friendly Gut Bact... | NCT03078010

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

NCT03078010

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Active, not recruiting

Last Update Posted

Mar 4, 2026Actual

Enrollment

347Actual

Phase

Phase 2

Conditions

Intestinal Microbiome
Febrile Neutropenia

Interventions

Piperacillin-tazobactam
cefepime

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2017Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2027Estimated

First Submitted Date

Mar 8, 2017

First Submission Date that Met QC Criteria

Mar 8, 2017

First Posted Date

Mar 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2026

Last Update Posted Date

Mar 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

347Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Piperacillin-tazobactam	Active Comparator		Drug: Piperacillin-tazobactam
cefepime	Experimental		Drug: cefepime

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Piperacillin-tazobactam	Drug	piperacillin-tazobactam (4.5 gm IV q 6 hrs)	Piperacillin-tazobactam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
measurement of fold-change in Clostridiales abundance	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.	7 +/- 2 days after initiation of piperacillin-tazobactam or cefepime

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Seo, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hackensack Meridian Health		Hackensack	New Jersey	07601	United States
Memorial Sloan Kettering Cancer Center

Label	URL
Memorial Sloan Kettering Cancer Center	View source

ID	Term
D064147	Febrile Neutropenia

ID	Term
D009503	Neutropenia
D000380	Agranulocytosis
D007970	Leukopenia
D000095542	Cytopenia

Intervention Browse Module

MeSH Terms

ID	Term
D000077725	Piperacillin, Tazobactam Drug Combination
D000077723	Cefepime

Ancestor Terms

ID	Term
D000078142	Tazobactam
D010397	Penicillanic Acid
D010406	Penicillins
D047090	beta-Lactams

Browse Leaves

Not provided

Browse Branches

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