Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options

Study Overview
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Brief Summary
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The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.

Official Title
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Multi-Center, Non-Interventional, Observational Study To Evaluate The Antibacterial Therapeutical Options In Febrile Neutropenia Patients

Conditions
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Febrile Neutropenia

Intervention / Treatment
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* Drug: Antibacterial agent for the treatment of febrile neutropenia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are 18 years old and above. Patients who have undergone allogeneic/autologous or peripheral stem cell transplantation following induction or consolidation treatment due to acute hematological malignancy. Patients who have a neutrophil count below 500 cells per cubic millimeter (cells/mm^3) or below 1000 cells/mm^3 with an expectancy to rapidly decrease below 500 cells/mm^3. Patients with a body temperature more than or equal to (≥)38.3 degrees Celsius (101 degrees Fahrenheit) on single oral measurement or detected ≥38.0 degrees Celsius for at least an hour and thus started on antibacterial treatment will be included in the trial. Exclusion Criteria: - Patients who are pregnant or considering pregnancy.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Participants with febrile neutropenia who received antibacterial treatment per investigator's judgment | Drug: Antibacterial agent for the treatment of febrile neutropenia<br>* The antibacterial agent used by the investigators for febrile neutropenia will be determined and classified in the preference order<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring Febrile Neutropenia (FEN) in Their Therapeutical Approach: Empirical |  | Baseline | 
| Percentage of Participants Receiving Antibacterial Agents Preferred by the Turkish Centers Monitoring FEN in Their Therapeutical Approach: Targeted |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Body Temperature |  | Baseline, Day 4, Day 7 on Average (till the End of Treatment) | 
| Mean Neutrophil Count |  | Baseline, Day 4, Day 7 on Average (till the End of Treatment) | 
| Percentage of Participants in Whom New Infection Was Determined on Day 4 |  | Day 4 | 
| Percentage of Participants in Whom New Infection Was Determined at End of Treatment |  | Day 7 on Average (till the End of Treatment) | 
| Percentage Survivors |  | Day 7 on Average (till the End of Treatment) | 
| Percentage of Participants Who Had a Treatment Modification |  | Day 4, Day 7 on Average (till the End of Treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibacterials, Classification of antibacterial agent, Febrile neutropenia, Turkey