Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients
- Conditions
- Myelodysplastic Syndrome
- Interventions
- Drug: Antibiotic and antifungal drugs
- Registration Number
- NCT01951430
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- All adult patients (>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation;
- Signed written informed consent;
- Psychiatric patients;
- Patients with life expectancy less than three months.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Myelodysplastic syndrome patients Antibiotic and antifungal drugs Patients affected by myelodysplastic syndrome enrolled in the observational study
- Primary Outcome Measures
Name Time Method Number of infectious events in myelodysplastic syndrome patients at 1 year from study entry Infectious events are fungal and antibiotic events
- Secondary Outcome Measures
Name Time Method Number of patients that needed granulocyte growth factors 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 Level of neutropenia at 1 year from study entry Number of patients who don't develop bacterial infection at 1 year from study entry Length of the hospitalization at 1 year from study entry Number of patients who recover from 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 without MDS progression at 1 year from study entry Level of iron overload At one 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 patient who don't develop fungal infection at 1 year from study entry Number of patients that needed iron sequestrating therapy caused by iron overload at 1 year from study entry Number of patients responding to therapy according to the administered treatment at 1 year from study entry Need for hospitalization at 1 year from study entry Level of International Prognostic Scoring System (IPSS)-revised At one year from study entry Number of MDS patients alive 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 Weeks of MDS suspension treatment at 1 year from study entry
Trial Locations
- Locations (25)
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
🇮🇹Cagliari, Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
🇮🇹Napoli, 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
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
🇮🇹Pesaro, Italy
U.O. di Ematologia - Centro Oncologico Basilicata
🇮🇹Rionero in Vulture, Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
🇮🇹Bari, Italy
Divisione di Ematologia Ospedale A. Perrin
🇮🇹Brindisi, Italy
Azienda Ospedaliera - Nuovo Ospedale 'Torrette'
🇮🇹Ancona, Italy
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
🇮🇹Genova, Italy
Policlinico di Careggi
🇮🇹Firenze, Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
🇮🇹Lecce, Italy
Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
🇮🇹Parma, 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
Università degli Studi - Policlinico di Tor Vergata
🇮🇹Roma, Italy
Complesso Ospedaliero S. Giovanni Addolorata
🇮🇹Roma, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
🇮🇹Roma, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
🇮🇹Roma, Italy
Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
🇮🇹Udine, 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