Study to Reduce Duration of Antibiotic Therapy in Haematological Patients With Fever and Neutropenia

Study Overview
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Brief Summary
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Clinical trial intended to reduce the antibiotic therapy duration in in-hospital patients with haematological diseases who develop fever and low white blood cell count (neutropenia).

Detailed Description
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The optimal duration of the empirical antimicrobial therapy (AT) in hematological patients with febrile neutropenia (FN) is unknown. The Infectious Diseases Society of America (IDSA) recommends maintaining AT at least until the neutropenia is recovered, because literally years of experience have proven this approach to be safe and effective. This recommendation is likely to cause unnecessarily prolonged treatments, and is against the urgent need of optimizing the antimicrobial therapy proposed by IDSA. The main objective of this study is to establish whether an individualized clinical protocol is better than the standard criteria (recovery of neutropenia as the criterion to suspend the empirical AT in hematological patients with FN).

Official Title
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Randomized Open Label Clinical Trial Directed to Optimize the Duration of Empirical Antimicrobial Therapy in Haematologic Patients With Febrile Neutropenia

Conditions
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Febrile Neutropenia

Intervention / Treatment
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* Drug: Empirical antimicrobial treatment discontinuation
* Drug: Standard empirical antimicrobial treatment discontinuation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (equal or older than 18 years) of both sexes admitted in the Department of Clinical Hematology who develop a febrile neutropenia. Including fever with unknown source and fever secondary to infection focus of clinical diagnosis without laboratory confirmation. Informed consent signed. Exclusion Criteria: Fever with etiologic diagnosis. Patients with epilepsy. Pregnant or lactating women. Patients with HIV infection. Patients with severe renal failure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Empirical antimicrobial treatment discontinuation | Drug: Empirical antimicrobial treatment discontinuation<br>* Empirical antimicrobial treatment discontinuation will occur when the patient is: Afebrile, with resolution of signs, symptoms and test abnormalities secondary to complementary source of infection and with normalization of vital signs for ≥ 72 h.<br>* Other names: Clinical rules for finalization of antimicrobial therapy;|
| Active Comparator: Control Arm<br>Standard empirical antimicrobial treatment discontinuation | Drug: Standard empirical antimicrobial treatment discontinuation<br>* The empirical antimicrobial treatment discontinuation will occur when the patient is: The neutrophil count is above 500 million per mm3.<br>* Other names: Laboratory rules for finalization of antimicrobial therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days on which patient is free of antimicrobial treatment | Protocol visits: Screening visit, Randomization visit, at 72h. of apyrexy (visit 1), at clinical recovery (visit 2), at recovery of neutropenia (visit 3), at relapsing fever (visit 4) and at 28 days (final visit). | 28 days following the initiation of empiric antibiotic treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crude mortality | Number of died patients | 28 days following the initiation of empiric antibiotic treatment. | 
| Number of days of fever | Number of days of fever | 28 days following the initiation of empiric antibiotic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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febrile neutropenia, antimicrobial treatment, procalcitonin