Hematologic MalignancySCENENCT04710212

Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies

An observational study of Hematologic Malignancy and Leukemia, Acute, run by Duke University at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (HCT) recipients are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematologic Malignancy, Leukemia, Acute, Neutropenia
How many people: 168 participants
Where: 6 sitesUnited States
Study dates: 12 Mar 2021to 28 Feb 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.

Who may be able to join

Ability to provide informed consent
Male or female ≥18 years of age
Receiving intensive induction chemotherapy for acute leukemia or undergoing HCT
Receive fluoroquinolone prophylaxis during neutropenia

Who cannot join

Expected to have <7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only)
First swab collected ≥5 days after onset of chemotherapy
First swab collected after the day of transplant (HCT cohort only)
Acute promyelocytic leukemia
Receiving chimeric antigen receptor (CAR)-T-cell therapy
Pregnant women as determined by clinician

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 25714
Mount Sinai Hospital
New York, New York, 10029
Hackensack Meridian Health
Nutley, New Jersey, 07110
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health and Science University
Portland, Oregon, 97239
University of California San Fransisco Medical Center
San Francisco, California, 94143

Other trials in United States

About this study

Official title: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)

Read the detailed description

The investigator will collect perianal swabs from patients receiving induction chemotherapy for acute leukemia or undergoing hematopoietic stem cell transplantation (HCT), and who are receiving fluoroquinolone (FQ) prophylaxis. FQRE colonization will be assessed by culture, and the investigator will correlate FQRE colonization with the risk of Gram-negative bacteremia during neutropenia.

Population: 410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.

Results of this study will be combined with a portion of subject data from an identically-designed R01-funded study of FQRE colonization. The combined data will be used for study analysis and reporting.

Conditions: Hematologic Malignancy, Leukemia, Acute, Neutropenia, Bloodstream Infection
Being tested: No intervention.
Keywords: FQRE, Fluoroquinolone-resistant Enterobacterales, Hematopoietic stem cell transplantation, HCT, Induction chemotherapy, Hematologic Malignancy, Acute Leukemia, Neutropenia, Bloodstream infection, Perianal swab, Gram-negative bacteremia
Medical subject headings: Hematologic Neoplasms, Leukemia, Neutropenia, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No intervention.Other
Observational study with no intervention.

Study groups in NCT04710212
Study group	Role	What they receive
Induction Chemotherapy for Acute Leukemia		Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis. Receives: Other: No intervention.
Hematopoietic stem cell transplantation (HCT)		Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis. Receives: Other: No intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Gram-negative bloodstream infection (BSI)
Gram-negative BSI during the episode of neutropenia
Measured: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days

Secondary outcomes (5)

Colonization with FQRE and ESBL-E
Colonization with fluoroquinolone-resistant Enterobacterales (FQRE) and Extended-spectrum-beta-lactamase-producing Enterobacterales (ESBL-E) upon initiation of chemotherapy
Measured: Within 4 days after initiation of chemotherapy
Fever
Occurrence (Yes/No) of fever (≥38.0°C) during the episode of neutropenia.
Measured: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Bloodstream infection (BSI)
Any BSI during the episode of neutropenia
Measured: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Intensive care unit (ICU) admission
Intensive care unit admission prior to recovery from neutropenia
Measured: Prior to neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
90-day mortality
90-day mortality from the collection of the first swab
Measured: Occurs within 90 days from the collection of the first swab

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 202128 Feb 2022

First posted14 Jan 2021
Study start12 Mar 2021
Primary completion30 Dec 2021
Study completion28 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04710212
Sponsor's protocol ID: Pro00106363
Other IDs: UM1AI104681
Acronym: SCENE
Status last verified: Mar 2022
First submitted: 11 Jan 2021
Last updated: 6 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 1/2
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All Hematologic Malignancy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)
ClinicalTrials.gov ID: NCT04710212
Acronym / sponsor ID: SCENE / Pro00106363
Conditions: Hematologic Malignancy, Leukemia, Acute, Neutropenia, Bloodstream Infection
Keywords: FQRE, Fluoroquinolone-resistant Enterobacterales, Hematopoietic stem cell transplantation, HCT, Induction chemotherapy, Hematologic Malignancy, Acute Leukemia, Neutropenia
Study type: Observational
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Weill Medical College of Cornell University, National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 12 Mar 2021 (actual)
Primary completion: 30 Dec 2021 (actual)
Study completion: 28 Feb 2022 (actual)
First posted: 14 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Population: 410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Induction Chemotherapy for Acute Leukemia	–	Other: No intervention.Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis.
Hematopoietic stem cell transplantation (HCT)	–	Other: No intervention.Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.

Key inclusion criteria (4 listed)

Ability to provide informed consent
Male or female ≥18 years of age
Receiving intensive induction chemotherapy for acute leukemia or undergoing HCT
Receive fluoroquinolone prophylaxis during neutropenia

Key exclusion criteria (6 listed)

Expected to have <7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only)
First swab collected ≥5 days after onset of chemotherapy
First swab collected after the day of transplant (HCT cohort only)
Acute promyelocytic leukemia
Receiving chimeric antigen receptor (CAR)-T-cell therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No intervention.Observational study with no intervention.	Other	Hematopoietic stem cell transplantation (HCT), Induction Chemotherapy for Acute Leukemia

Primary outcome

Gram-negative bloodstream infection (BSI)
Time frame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Gram-negative BSI during the episode of neutropenia

5 secondary outcomes

Colonization with FQRE and ESBL-E
Time frame: Within 4 days after initiation of chemotherapy
Fever
Time frame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Bloodstream infection (BSI)
Time frame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Intensive care unit (ICU) admission
Time frame: Prior to neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
90-day mortality
Time frame: Occurs within 90 days from the collection of the first swab

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Individual participant dataSharing planned: No

Related trials for Hematologic Malignancy

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Satlin principal investigator

Weill Medical College of Cornell University

Vance G Fowler, MD study director

Duke Clinical Research Institute

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Malignancy and Leukemia, Acute, run by Duke University at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gram-negative bloodstream infection (BSI) (time frame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04710212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.