Clinical trial · Observational
AMS Intervention for Early Adaptation of Empirical Antibiotic Therapy in High-risk Neutropenic Patients
Efficacy of an Antimicrobial Stewardship Intervention for Early Adaptation of Empirical Antibiotic Therapy in High-risk Neutropenic Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Pre-intervention group
- label
- Post-intervention group
Primary outcomes (1)
- measure
- Total antibiotic use during hospital stay, expressed as days of therapy (DOT)
- timeFrame
- 31 months
- description
- 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.
Secondary outcomes (6)
- measure
- Total antibiotic use during hospital stay, expressed as days of therapy (LOT)
- timeFrame
- 31 months
- description
- LOT was defined as the number of days that a patient received systemic antibiotic therapy, irrespective of the number of different antibiotics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients admitted to the hematology department for intensive chemotherapy, with chemotherapy-induced neutropenia lasting 7 days or more, who experienced at least one febrile episode, were eligible for inclusion. Exclusion Criteria: * Younger than 18 years old * Had chemotherapy-induced neutropenia for less than 7 days or received corticosteroids.
References
Publications (0)
Data not yet available