NCT05824689 · REGISTRY CONDITION SEARCH

Fluoroquinolone Resistance Prevalence Study

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: Not reported
Status at capture: TERMINATED
Registry last update: 2026-06-05

This is an exploratory study to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM). These data may be used in subsequent studies exploring the use of prophylaxis in this patient population.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Prevalence of FRE

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outcome · POSTED

Occurrence/Risk of Febrile Neutropenia (FN)

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outcome · POSTED

Occurrence/Risk of Blood Stream Infection (BSI)

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outcome · POSTED

Comparison of Length of Stay (LOS) Between FRE Carriers and FRE Non-carriers

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outcome · POSTED

Comparison of Engraftment Kinetics Between FRE Carriers and FRE Non-carriers

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outcome · POSTED

Comparison of Severity of GI Toxicity Between FRE Carriers and FRE Non-carriers

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outcome · NOT POSTED

Comparison of Effect of FRE Colonization and Fluoroquinolone Prophylaxis on the Microbiome Between FRE Carriers and FRE Non-carriers

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Subjects \>18 yrs of age. * Diagnosis of multiple myeloma undergoing (first or subsequent) autologous PBSC transplantation. * Transplant conditioning with melphalan 200 mg/m2. * PBSC cell dose of \>2x10e6 CD34+ cells/kg. * Able to receive fluoroquinolone prophylaxis. * Subjects must give consent for enrollment into this study. Exclusion Criteria: * Unwillingness to provide informed consent. * Enrollment into a treatment protocol prescribing antibiotic prophylaxis. * A diagnosis other than multiple myeloma. * Receiving a conditioning regimen other than melphalan 200 mg/m2. * Known light-chain amyloid deposition in any organ.
healthy Volunteers: false
minimum Age: 18 Years
sampling Method: NON_PROBABILITY_SAMPLE
sex: ALL
std Ages: ADULT
OLDER_ADULT
study Population: Subjects eligible for this study will meet the defined eligibility criteria to undergo autologous transplantation established at the transplant centers as per standard of care (SOC). All adult patients with a diagnosis of multiple myeloma undergoing autologous transplantation after dose-intense melphalan conditioning are candidates for enrollment into this study. These subjects will be approached for enrollment into this study by the transplant attending physician caring for the patient.

Treatment arms and interventions

Study design

observational Model: OTHER
time Perspective: PROSPECTIVE

Enrollment

count: 124
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Comparison of effect of FRE colonization and fluoroquinolone prophylaxis on the microbiome between FRE carriers and FRE non-carriers
measure
Comparison of Effect of FRE Colonization and Fluoroquinolone Prophylaxis on the Microbiome Between FRE Carriers and FRE Non-carriers
time Frame
Duration between Apheresis Consultation and Day +100

primary Outcomes

description
Prevalence of FRE in patients undergoing autologous PBSC transplantation with dose-intense melphalan
measure
Prevalence of FRE
time Frame
Duration between Apheresis Consultation and Day +100

secondary Outcomes

description
Occurrence of neutropenic fever during the first 28 days (4 weeks) after autologous PBSC transplantation in the treatment of multiple myeloma.
measure
Occurrence/Risk of Febrile Neutropenia (FN)
time Frame
Within 28 days of the transplantation
description
The occurrence of Gram-negative BSI among the FRE carriers and FRE non-carriers
measure
Occurrence/Risk of Blood Stream Infection (BSI)
time Frame
Within 28 days of the transplantation
description
Comparison of Length of Stay (LOS) between FRE carriers and FRE non-carriers by estimating time to discharge
measure
Comparison of Length of Stay (LOS) Between FRE Carriers and FRE Non-carriers
time Frame
Duration between Day of hospital admission and Day of hospital discharge (estimated duration between 11 - 15 days)
description
Comparison of Engraftment Kinetics (absolute neutrophil count (ANC), absolute lymphocyte count (ALC), platelet) between FRE carriers and FRE non-carriers
measure
Comparison of Engraftment Kinetics Between FRE Carriers and FRE Non-carriers
time Frame
Duration between Apheresis Consultation and Day +100
description
Comparison of severity of GI toxicity between FRE carriers and FRE non-carriers per the grade of GI toxicity
measure
Comparison of Severity of GI Toxicity Between FRE Carriers and FRE Non-carriers
time Frame
Duration between Apheresis Consultation and Day +100

Full study description

brief Summary: This is an exploratory study to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM). These data may be used in subsequent studies exploring the use of prophylaxis in this patient population.
detailed Description: The goal of this observational study is to determine the prevalence of fluoroquinolone resistance in patients receiving dose-intense melphalan with autologous peripheral blood stem cell (PBSC) transplantation in the treatment of multiple myeloma (MM). The main question\[s\] it aims to answer are: * What is the prevalence of fluoroquinolone-resistant Enterobacterales (FRE) in patients undergoing autologous PBSC transplantation with dose-intense melphalan? * Does the risk of febrile neutropenia differ in FRE carriers compared to non-carriers? Participants will be tested for the presence of FRE before receiving fluoroquinolone prophylaxis at multiple points during the transplant course, including before chemotherapy mobilization (if used) using fluoroquinolone prophylaxis, at initial transplant hospitalization, at time of hospital discharge, and at or after day 84 after transplantation (day 0 is defined as day of HSC (hematopoietic stem cell) infusion). FRE colonization will not be a determining factor in the use of fluoroquinolone prophylaxis during the treatment course. This study will be open at two transplant units: Hackensack University Medical Center (HUMC) and MedStar Georgetown University Hospital (MGUH). Estimated number of subjects to be enrolled; * HUMC: 124 * MGUH: 20 Anticipated enrollment period: 12-months with monitoring of subjects for 84 days (twelve weeks) after transplantation. Data will be analyzed over a three-month period (total study period of 18 months).

Source references

references

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