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.
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.
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
About this study
Official title: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)
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 the detailed description
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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Michael Satlin, Principal investigator, Weill Medical College of Cornell UniversityVance G Fowler, MD, Study director, Duke Clinical Research Institute
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
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
- 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.
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.
Detailed description
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.
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.
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
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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?
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; AzTrials last refreshed its copy on 7 Nov 2026.