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NCT04910698 Clinical Trial

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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04910698
Other study ID # Antibioshort neutropenia
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date June 1, 2020

Study information
Verified date May 2021
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France University Hospital Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bloodstream infection relapses 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 Mortality Comparison of mortality rate within 30 days of antibiotic discontinuation within 30 days of antibiotic discontinuation
Secondary Epidemiology of bacteria Distribution of bacteria responsible for bloodstream infection at baseline
Secondary Risk factors for relapses Analyse of risk factors for bloodstream infection relapses within 30 days of antibiotic discontinuation
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