NCT05793073

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

Completed Last updated 31 March 2023

What this trial tests

trial in Neutropenia in 55 participants. Completed in 31 May 2022.

Timeline

1 October 2019

Primary endpoint
28 February 2022

31 May 2022

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Status	Completed
Study type	OBSERVATIONAL
Enrollment	55
Start date	1 October 2019
Primary completion	28 February 2022
Estimated completion	31 May 2022
Sites	1 location across France

Conditions studied

• Neutropenia — all drugs for Neutropenia →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

18 and older, any sex, with Neutropenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.