Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients

NCT ID: NCT01951430

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2020-10-29

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.

Conditions

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Myelodysplastic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Myelodysplastic syndrome patients

Patients affected by myelodysplastic syndrome enrolled in the observational study

Antibiotic and antifungal drugs

Intervention Type DRUG

Interventions

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Antibiotic and antifungal drugs

Intervention Type DRUG

Other Intervention Names

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levofloxacine; cyprofloxacine; co-trimoxazole; chinolones; cephalosporins; penicillines; other betalactams; macrolids; posaconazole; fluconazole; itraconazole.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Livio Pagano, Dr.

Role: PRINCIPAL_INVESTIGATOR

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma

Locations

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S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

Alessandria, , Italy

Site Status

Azienda Ospedaliera - Nuovo Ospedale 'Torrette'

Ancona, , Italy

Site Status

UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro

Bari, , Italy

Site Status

Divisione di Ematologia Ospedale A. Perrin

Brindisi, , Italy

Site Status

ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

Cagliari, , Italy

Site Status

Policlinico di Careggi

Florence, , Italy

Site Status

IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente

Genova, , Italy

Site Status

ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

Lecce, , Italy

Site Status

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, , Italy

Site Status

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, , Italy

Site Status

Università degli Studi di Padova - Ematologia ed Immunologia Clinica

Padua, , Italy

Site Status

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

Site Status

Cattedra di Ematologia CTMO Università degli Studi di Parma

Parma, , Italy

Site Status

Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo

Pavia, , Italy

Site Status

Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore

Pesaro, , Italy

Site Status

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, , Italy

Site Status

Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza

Piacenza, , Italy

Site Status

U.O. di Ematologia - Centro Oncologico Basilicata

Rionero in Vulture, , Italy

Site Status

Complesso Ospedaliero S. Giovanni Addolorata

Roma, , Italy

Site Status

U.O.C. Ematologia - Ospedale S.Eugenio

Roma, , Italy

Site Status

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, , Italy

Site Status

Università degli Studi - Policlinico di Tor Vergata

Roma, , Italy

Site Status

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, , Italy

Site Status

Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

Torino, , Italy

Site Status

Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine

Udine, , Italy

Site Status

Countries

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Italy

Related Links

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Other Identifiers

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MDS0413

Identifier Type: -

Identifier Source: org_study_id

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