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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Bloodstream Infection
• Communicable Diseases
• Febrile Neutropenia
• Fever
• Infection
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Neutropenia
• Sepsis

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