- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04910698
Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia
June 1, 2021 updated by: Poitiers University Hospital
Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study
There is no specific recommendation about antimicrobial treatment length for documented infections in chemotherapy induced febrile neutropenia.
The aim of this study was to compare long versus short antibiotic course for bloodstream infection treatment in acute myeloid leukemia patients during febrile neutropenia.
This monocentric retrospective comparative study included all consecutive bloodstream infection episodes among acute myeloid leukemia patients with febrile neutropenia for 3 years (2017-2019).
Episodes were classified regarding the length of antibiotic treatment, considered as short course if the treatment lasted ≤7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was ≤10 days and ≤14 days, respectively.
The primary outcome was the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
104
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Poitiers, France, 86000
- University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All bloodstream infection episodes occuring in patients suffering from febrile neutropenia during acute myeloid leukemia between January 2017 and December 2019 in University Hospital of Poitiers were included.
Description
Inclusion Criteria:
- Acute myeloid leukemia
- chemo-induced febrile neutropenia
- Bloodstream infection
Exclusion Criteria:
- lack of data
- endovascular infections
- surgical treatment required
- central nervous system infections
- antibiotic treatment < 4 days
- death before the end of antibiotic treatment
- unappropriated antibiotic treatment at 48h
- relapses of bloodstream infection episodes already included
- hematopoietic stem cell transplant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Short course treatment
Patients who received antibiotic for 7 or less days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was 10 days and 14 days, respectively.
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Antibiotic duration of treatment defined if the patient belonged to long course or short course group.
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|
Long course treatment
Patients who received antibiotic for more than 7 days, except for nonfermenting bacteria and Staphylococcus aureus or lugdunensis for which the threshold was 10 days and 14 days, respectively.
|
Antibiotic duration of treatment defined if the patient belonged to long course or short course group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bloodstream infection relapses
Time Frame: within 30 days of antibiotic discontinuation
|
The primary outcome was to compare the number of bloodstream infection relapses in both groups within 30 days of antibiotic discontinuation.
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within 30 days of antibiotic discontinuation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: within 30 days of antibiotic discontinuation
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Comparison of mortality rate within 30 days of antibiotic discontinuation
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within 30 days of antibiotic discontinuation
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Epidemiology of bacteria
Time Frame: at baseline
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Distribution of bacteria responsible for bloodstream infection
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at baseline
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Risk factors for relapses
Time Frame: within 30 days of antibiotic discontinuation
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Analyse of risk factors for bloodstream infection relapses
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within 30 days of antibiotic discontinuation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: France Cazenave-Roblot
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
May 27, 2021
First Submitted That Met QC Criteria
June 1, 2021
First Posted (Actual)
June 2, 2021
Study Record Updates
Last Update Posted (Actual)
June 2, 2021
Last Update Submitted That Met QC Criteria
June 1, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Systemic Inflammatory Response Syndrome
- Inflammation
- Wounds and Injuries
- Disease Attributes
- Hematologic Diseases
- Agranulocytosis
- Leukopenia
- Leukocyte Disorders
- Body Temperature Changes
- Heat Stress Disorders
- Sepsis
- Infections
- Communicable Diseases
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Neutropenia
- Hyperthermia
- Fever
- Febrile Neutropenia
- Anti-Infective Agents
- Anti-Bacterial Agents
Other Study ID Numbers
- Antibioshort neutropenia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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