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

Completed

• Conditions: Bloodstream Infection; Acute Myeloid Leukemia; Febrile Neutropenia
• Interventions: Drug: Antibiotic

• Registration Number: NCT04910698
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Study First Posted: 2021-06-02
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Short course treatment	Antibiotic	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.
Long course treatment	Antibiotic	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mortality	within 30 days of antibiotic discontinuation	Comparison of mortality rate within 30 days of antibiotic discontinuation
Epidemiology of bacteria	at baseline	Distribution of bacteria responsible for bloodstream infection
Risk factors for relapses	within 30 days of antibiotic discontinuation	Analyse of risk factors for bloodstream infection relapses

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Poitiers, France