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

Sponsor
Poitiers University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04910698
Collaborator
(none)
104
1
5
20.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
104 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Efficacy of Antibiotic Short Course for Bloodstream Infections in Acute Myeloid Leukemia Patients With Febrile Neutropenia: a Retrospective Comparative Study
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm 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.

Drug: Antibiotic
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.

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

Outcome Measures

Primary Outcome Measures

  1. Bloodstream infection relapses [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 Outcome Measures

  1. Mortality [within 30 days of antibiotic discontinuation]

    Comparison of mortality rate within 30 days of antibiotic discontinuation

  2. Epidemiology of bacteria [at baseline]

    Distribution of bacteria responsible for bloodstream infection

  3. Risk factors for relapses [within 30 days of antibiotic discontinuation]

    Analyse of risk factors for bloodstream infection relapses

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Poitiers France 86000

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

  • Study Director: France Cazenave-Roblot,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT04910698
Other Study ID Numbers:
  • Antibioshort neutropenia
First Posted:
Jun 2, 2021
Last Update Posted:
Jun 2, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Poitiers University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2021