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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myelodysplastic syndrome patients | Patients affected by myelodysplastic syndrome enrolled in the observational study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic and antifungal drugs | Drug |
|
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Adult myelodysplastic syndrome patients
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| Name | Affiliation | Role |
|---|---|---|
| Livio Pagano, Dr. | Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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| 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. |
| Azienda Ospedaliera - Nuovo Ospedale 'Torrette' |
| Ancona |
| Italy |
| UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro | Bari | Italy |
| Divisione di Ematologia Ospedale A. Perrin | Brindisi | Italy |
| ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO | Cagliari | Italy |
| Policlinico di Careggi | Florence | Italy |
| IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente | Genova | Italy |
| ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE | Lecce | Italy |
| Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia | Naples | Italy |
| S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro | Novara | Italy |
| Università degli Studi di Padova - Ematologia ed Immunologia Clinica | Padova | Italy |
| U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone" | Palermo | Italy |
| Cattedra di Ematologia CTMO Università degli Studi di Parma | Parma | Italy |
| Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo | Pavia | Italy |
| Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore | Pesaro | Italy |
| U.O. Ematologia Clinica - Azienda USL di Pescara | Pescara | Italy |
| Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza | Piacenza | Italy |
| U.O. di Ematologia - Centro Oncologico Basilicata | Rionero in Vulture | Italy |
| Complesso Ospedaliero S. Giovanni Addolorata | Roma | Italy |
| U.O.C. Ematologia - Ospedale S.Eugenio | Roma | Italy |
| Università Cattolica del Sacro Cuore - Policlinico A. Gemelli | Roma | Italy |
| Università degli Studi - Policlinico di Tor Vergata | Roma | Italy |
| Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy |
| Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista | Torino | Italy |
| Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine | Udine | Italy |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D000935 | Antifungal Agents |
| D015242 | Ofloxacin |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| D002511 | Cephalosporins |
| C101425 | posaconazole |
| D015725 | Fluconazole |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D013843 | Thiazines |
| D014230 | Triazoles |
| D001393 | Azoles |
| D010879 | Piperazines |
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