Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients

Study Overview
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Brief Summary
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The purpose of this study is to observe the number of new cases of infections per population in a given time period and their characteristics in a pathology (myelodysplastic syndrome, MDS)that involves ineffective production (or dysplasia) of a class of blood cells.

Detailed Description
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The scarcity and the inadequacy of data make impossible the writing of evidence-based recommendations for prevention and management of infections in myelodysplastic syndrome. The aim of this study is to evaluate the incidence and the spectrum of the infections of MDS patients. Will be also evaluated potential risk factors. This study could help the definition of the optimal management of MDS patients in terms of prophylaxis of the infective complications and in terms of the correct administration of growth factors.

Official Title
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Observational Prospective Multicenter Study to Evaluate the Infective Risk in Myelodysplastic Syndrome Patients: Antimicrobial Prophylaxis and Granulocyte Growth Factors.

Conditions
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Myelodysplastic Syndrome

Intervention / Treatment
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* Drug: Antibiotic and antifungal drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients (>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation; Signed written informed consent; Exclusion Criteria: Psychiatric patients; Patients with life expectancy less than three months.

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 |
| --- | --- |
| Myelodysplastic syndrome patients<br>Patients affected by myelodysplastic syndrome enrolled in the observational study | Drug: Antibiotic and antifungal drugs<br> <br> * Other names: itraconazole.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infectious events in myelodysplastic syndrome patients | Infectious events are fungal and antibiotic events | at 1 year from study entry | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of MDS patients with a febrile event treated with antibiotic, antifungal and antiviral therapy |  | at 1 year from study entry | 
| Level of neutropenia |  | at 1 year from study entry | 
| Number of patients who recover from infection |  | at 1 year from study entry | 
| Number of patients recovered from infection out of the total of patients with documented infection during the observational period |  | at 1 year from study entry | 
| Number of patients who don't develop bacterial infection |  | at 1 year from study entry | 
| Number of patient who don't develop fungal infection |  | at 1 year from study entry | 
| Number of patient who don't develop viral infection |  | at 1 year from study entry | 
| Number of patients that needed granulocyte growth factors |  | at 1 year from study entry | 
| Number of patients that needed iron sequestrating therapy caused by iron overload |  | at 1 year from study entry | 
| Length of the hospitalization |  | at 1 year from study entry | 
| Weeks of MDS suspension treatment |  | at 1 year from study entry | 
| Number of patients responding to therapy according to the administered treatment |  | at 1 year from study entry | 
| Number of MDS patients alive |  | at 1 year from study entry | 
| Number of patients without MDS progression |  | at 1 year from study entry | 
| Need for hospitalization |  | at 1 year from study entry | 
| Level transfusion dependence |  | At one year from study entry | 
| Level of MDS subtype |  | At one year from study entry | 
| Level of risk of International Prognostic Scoring System (IPSS) |  | At one year from study entry | 
| Level of International Prognostic Scoring System (IPSS)-revised |  | At one year from study entry | 
| Level of iron overload |  | At one year from study entry. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult patients, Infective events, Antibiotic, Antifungal, Myelodysplastic syndrome