Myelodysplastic Syndrome
Conditions
Keywords
Adult patients, Infective events, Antibiotic, Antifungal, Myelodysplastic syndrome
Brief summary
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
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.
Interventions
DRUGAntibiotic and antifungal drugs
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of infectious events in myelodysplastic syndrome patients | at 1 year from study entry | Infectious events are fungal and antibiotic events |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of MDS patients with a febrile event treated with antibiotic, antifungal and antiviral therapy | 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. |
| Weeks of MDS suspension treatment | at 1 year from study entry |
Countries
Italy
Outcome results
None listed