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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECIL-4 guidelines group | For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia: - From 1st February 2014 to 30th November 2014, antibiotics were stopped when patients had been afebrile for more than 48 hours, as recommended by the ECIL-4 guidelines |
| |
| short-course antibiotic therapy | For the FUO group, antibiotics were stopped based on two procedures, irrespective of the neutrophil count or expected duration of neutropenia: - From 1st December 2014 to 30th September 2015, antibiotics were stopped on day 5 in febrile or afebrile patients (short-course antibiotic therapy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECIL-4 guidelines group | Other | Antibiotics were stopped when patients had been afebrile for more than 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of a short-term antibiotic treatment in afebrile or febrile patients exhibiting FUO, irrespective of their neutrophil count. | mortality, intensive care admissions, infection | Month 1 |
| tolerability of a short-term antibiotic treatment in afebrile or febrile | Duration of antibiotic therapy (days), duration of fever (days) | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Epidemiology of febrile neutropenia | Clinical and biological data | Month 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient admitted to the Department of Clinical Haematology of Brest Teaching Hospital (France) was eligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Gaelle Guillerm, MD | Department of Hematology, Brest Teaching Hospital, Hospital Morvan, Avenue Foch, 29200 Brest, France | Principal Investigator |
| Jean-Philippe Talarmin, MD | Department of Internal Medicine, Infectious Diseases and Hematology, Cornouaille Hospital Quimper, Avenue Yves Thépot, 29000 Quimper, France | Principal Investigator |
| Lenaïg Le Clech, MD | Department of Hematology, Brest Teaching Hospital, Hospital Morvan, Avenue Foch, 29200 Brest, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest | Brest | 29609 | France |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
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| Short-course antibiotic therapy | Other | Antibiotics were stopped on day 5 in febrile or afebrile patients |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |