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

      • Poitiers, France, 86000
        • University Hospital

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.
Antibiotic duration of treatment defined if the patient belonged to long course or short course group.
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.
within 30 days of antibiotic discontinuation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: within 30 days of antibiotic discontinuation
Comparison of mortality rate within 30 days of antibiotic discontinuation
within 30 days of antibiotic discontinuation
Epidemiology of bacteria
Time Frame: at baseline
Distribution of bacteria responsible for bloodstream infection
at baseline
Risk factors for relapses
Time Frame: within 30 days of antibiotic discontinuation
Analyse of risk factors for bloodstream infection relapses
within 30 days of antibiotic discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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