Clinical trial NCT01951430: Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients
Official title: Observational Prospective Multicenter Study to Evaluate the Infective Risk in Myelodysplastic Syndrome Patients: Antimicrobial Prophylaxis and Granulocyte Growth Factors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome
Keywords: Adult patients
Infective events
Antibiotic
Antifungal
Myelodysplastic syndrome
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult myelodysplastic syndrome patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of infectious events in myelodysplastic syndrome patients
timeFrame: at 1 year from study entry
Secondary outcomes:
measure: Number of MDS patients with a febrile event treated with antibiotic, antifungal and antiviral therapy
timeFrame: at 1 year from study entry
measure: Level of neutropenia
timeFrame: at 1 year from study entry
measure: Number of patients who recover from infection
timeFrame: at 1 year from study entry
measure: Number of patients recovered from infection out of the total of patients with documented infection during the observational period
timeFrame: at 1 year from study entry
measure: Number of patients who don't develop bacterial infection
timeFrame: at 1 year from study entry
measure: Number of patient who don't develop fungal infection
timeFrame: at 1 year from study entry
measure: Number of patient who don't develop viral infection
timeFrame: at 1 year from study entry
measure: Number of patients that needed granulocyte growth factors
timeFrame: at 1 year from study entry
measure: Number of patients that needed iron sequestrating therapy caused by iron overload
timeFrame: at 1 year from study entry
measure: Length of the hospitalization
timeFrame: at 1 year from study entry
measure: Weeks of MDS suspension treatment
timeFrame: at 1 year from study entry
measure: Number of patients responding to therapy according to the administered treatment
timeFrame: at 1 year from study entry
measure: Number of MDS patients alive
timeFrame: at 1 year from study entry
measure: Number of patients without MDS progression
timeFrame: at 1 year from study entry
measure: Need for hospitalization
timeFrame: at 1 year from study entry
measure: Level transfusion dependence
timeFrame: At one year from study entry
measure: Level of MDS subtype
timeFrame: At one year from study entry
measure: Level of risk of International Prognostic Scoring System (IPSS)
timeFrame: At one year from study entry
measure: Level of International Prognostic Scoring System (IPSS)-revised
timeFrame: At one year from study entry
measure: Level of iron overload
timeFrame: At one year from study entry.
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Azienda Ospedaliera - Nuovo Ospedale 'Torrette'
city: Bari
country: Italy
facility: UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
city: Brindisi
country: Italy
facility: Divisione di Ematologia Ospedale A. Perrin
city: Cagliari
country: Italy
facility: ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
city: Firenze
country: Italy
facility: Policlinico di Careggi
city: Genova
country: Italy
facility: IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
city: Lecce
country: Italy
facility: ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
city: Novara
country: Italy
facility: S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
city: Padova
country: Italy
facility: Università degli Studi di Padova - Ematologia ed Immunologia Clinica
city: Palermo
country: Italy
facility: 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"
city: Parma
country: Italy
facility: Cattedra di Ematologia CTMO Università degli Studi di Parma
city: Pavia
country: Italy
facility: Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
city: Pesaro
country: Italy
facility: Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
city: Pescara
country: Italy
facility: U.O. Ematologia Clinica - Azienda USL di Pescara
city: Piacenza
country: Italy
facility: Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
city: Rionero in Vulture
country: Italy
facility: U.O. di Ematologia - Centro Oncologico Basilicata
city: Roma
country: Italy
facility: Complesso Ospedaliero S. Giovanni Addolorata
city: Roma
country: Italy
facility: U.O.C. Ematologia - Ospedale S.Eugenio
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
city: Roma
country: Italy
facility: Università degli Studi - Policlinico di Tor Vergata
city: San Giovanni Rotondo
country: Italy
facility: Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
city: Udine
country: Italy
facility: Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
Study officials:
affiliation: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma
name: Livio Pagano, Dr.
role: PRINCIPAL_INVESTIGATOR
References: