AMS Intervention for Early Adaptation of Empirical Antibiotic Therapy in High-risk Neutropenic Patients

NCT05793073 | Completed

• 1 other identifier: 23Infectio01
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Febrile neutropenia (FN) is a frequent and serious complication in patients with hematological malignancies undergoing intensive chemotherapy. The growth of antibiotic resistance is a major threat in high-risk neutropenic patients given that delay in introduction of appropriate empirical antibiotic therapy (EAT) in this population is associated with increased morbidity and mortality. In 2013, the 4th European Conference on Infections in Leukaemia (ECIL-4) group published new guidelines, promoting early adaptation of EAT in stable afebrile patients, regardless of neutrophil count and expected duration of neutropenia. Despite these evidence-based guidelines, discontinuation and de-escalation strategies are not widely implemented in hematology departments. However, recent studies have found that early adaptation of EAT is safe and feasible and could lead to reduced antibiotic consumption. In response to growing antibiotic resistance and low adherence to ECIL-4 guidelines in the hematology department in the center of Nice, the investigators have developed and implemented a multifaceted AMS intervention. This intervention aimed to improve the quality of febrile neutropenia management and to promote the adoption of early de-escalation and discontinuation strategies in high-risk neutropenic patients by our hematology team. The aim of this before-after study was to assess the impact of a multifaceted AMS intervention, promoting early adaptation of empirical antibiotic therapy, on antibiotic consumption and clinical outcomes in high-risk neutropenic patients. Secondly, the investigators sought to assess the applicability and adherence to de-escalation and discontinuation strategies by the hematology team. The primary endpoint was total antibiotic use during hospital stay, expressed as days of therapy (DOT). DOT was defined as the number of days that a patient received antibiotics regardless of the dose. Secondary endpoints included length of therapy (LOT), antibiotic-free days (AFD), 30-day mortality, ICU admission, Clostridium difficile infection and duration of stay. LOT was defined as the number of days that a patient received systemic antibiotic therapy, irrespective of the number of different antibiotics.

Conditions

Neutropenia

Keywords

antibiotic; antimicrobial stewardship; hematological malignancy; febrile neutropenia

Outcome Measures

Primary Outcomes (1)

• Total antibiotic use during hospital stay, expressed as days of therapy (DOT)

  DOT was defined as the number of days that a patient received antibiotics regardless of the dose. When a patient received more than one antibiotic, more than one DOT was counted.

  31 months

Secondary Outcomes (6)

• Total antibiotic use during hospital stay, expressed as days of therapy (LOT)

  31 months

• Antibiotic-free days (AFD)

  31 months

• 30-day mortality rate

  31 months

• ICU admission rate

  31 months

• Clostridium difficile infection rate

  31 months

Study Arms (2)

Pre-intervention group

Post-intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with febril neutropenia due to intensive chemotherapy

You may not qualify if:

• Younger than 18 years old
• Had chemotherapy-induced neutropenia for less than 7 days or received corticosteroids.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

University Hospital of Nice

Nice, 06200, France

Location

MeSH Terms

Conditions

Neutropenia; Hematologic Neoplasms; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms

Study Design

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

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 31, 2023
• Study Start: October 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: May 31, 2022
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)