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

NCT04910698 | Completed

• 1 other identifier: Antibioshort neutropenia
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Bloodstream Infection; Acute Myeloid Leukemia; Febrile Neutropenia

Keywords

antibiotic short course, appropriate use of antibiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mortality

  within 30 days of antibiotic discontinuation

• Epidemiology of bacteria

  at baseline

• Risk factors for relapses

  within 30 days of antibiotic discontinuation

Study Arms (2)

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

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

Interventions

Antibiotic DRUG

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

Long course treatment; Short course treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All bloodstream infection episodes occuring in patients suffering from febrile neutropenia during acute myeloid leukemia between January 2017 and December 2019 in University Hospital of Poitiers were included.

You may qualify if:

• Acute myeloid leukemia
• chemo-induced febrile neutropenia
• Bloodstream infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

University Hospital

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Sepsis; Leukemia, Myeloid, Acute; Febrile Neutropenia

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• France Cazenave-Roblot

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

FR (1)