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Completed

NCT Number: NCT04910698

Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia

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.

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Key information

Conditions

Bloodstream Infection Acute Myeloid Leukemia Agranulocytosis Cytopenia Febrile Neutropenia Hematologic Diseases Hemic and Lymphatic Diseases Infections Inflammation Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Histologic Type Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic

Drug

Antibiotic duration of treatment defined if the patient belonged to long course or short course group.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality

    Time frame: within 30 days of antibiotic discontinuation

    Comparison of mortality rate within 30 days of antibiotic discontinuation

  2. Epidemiology of bacteria

    Time frame: at baseline

    Distribution of bacteria responsible for bloodstream infection

  3. Risk factors for relapses

    Time frame: within 30 days of antibiotic discontinuation

    Analyse of risk factors for bloodstream infection relapses

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2021
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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