Febrile Neutropenia, Hematological Malignancy
Conditions
Brief summary
Febrile neutropenia requires prompt initiation of broad-spectrum antibiotics, which can be responsible for side-effects and selection of resistance. This study demonstrates the safety of an early discontinuation of empirical treatments, in carefully selected patients presenting with fever of unknown origin.
Detailed description
Infections are responsible for significant morbidity and mortality in haematological patients, in particular during chemotherapy-induced neutropenia. Guidelines recommend immediate initiation of antibiotic therapy, whose optimal duration is unclear. The primary objective of this study is to evaluate early discontinuation of antibiotic treatment for Fever of Unknown Origin (FUO) in afebrile or febrile neutropenic patients. The secondary objective is to describe the epidemiology of febrile neutropenia (FN) in investigator centre. Every episode of FN was prospectively identified. In the first phase of the study, empirical antibiotic therapy of FUO patients was stopped after 48 hours of apyrexia, in accordance with ECIL-4 (European Conference on Infections in Leukaemia) recommendations. In the second phase of the study, antibiotics were stopped on day 5 for all FUO patients, regardless of their temperature or their leukocyte count.
Interventions
OTHERECIL-4 guidelines group
Antibiotics were stopped when patients had been afebrile for more than 48 hours
OTHERShort-course antibiotic therapy
Antibiotics were stopped on day 5 in febrile or afebrile patients
Sponsors
University Hospital, Brest
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years; * presence of a malignant haematological disease combined with chemotherapy-induced neutropenia (polymorphonuclear neutrophil (PMN) count ≤ 500/mm3) * fever defined by tympanic temperature of ≥38°C for ≥1 hour or a single temperature of ≥38.3°C
Exclusion criteria
* Patients without curative care * chronic neutropenia (PMN≤ 500/mm3 for 3 months or more)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of a short-term antibiotic treatment in afebrile or febrile patients exhibiting FUO, irrespective of their neutrophil count. | Month 1 | mortality, intensive care admissions, infection |
| tolerability of a short-term antibiotic treatment in afebrile or febrile | Month 1 | Duration of antibiotic therapy (days), duration of fever (days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epidemiology of febrile neutropenia | Month 1 | Clinical and biological data |
Countries
France
Outcome results
None listed