Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients

Myelodysplastic Syndrome Clinical Trial

Official title:

Observational Prospective Multicenter Study to Evaluate the Infective Risk in Myelodysplastic Syndrome Patients: Antimicrobial Prophylaxis and Granulocyte Growth Factors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951430
• Other study ID #: MDS0413
• Status: Completed
• Start date: March 2014
• Est. completion date: October 29, 2020

Study information

• Verified date: September 2021
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Antibiotic and antifungal drugs

Locations

Country	Name	City	State
Italy	S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	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	Firenze
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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infectious events in myelodysplastic syndrome patients	Infectious events are fungal and antibiotic events	at 1 year from study entry
Secondary	Number of MDS patients with a febrile event treated with antibiotic, antifungal and antiviral therapy		at 1 year from study entry
Secondary	Level of neutropenia		at 1 year from study entry
Secondary	Number of patients who recover from infection		at 1 year from study entry
Secondary	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
Secondary	Number of patients who don't develop bacterial infection		at 1 year from study entry
Secondary	Number of patient who don't develop fungal infection		at 1 year from study entry
Secondary	Number of patient who don't develop viral infection		at 1 year from study entry
Secondary	Number of patients that needed granulocyte growth factors		at 1 year from study entry
Secondary	Number of patients that needed iron sequestrating therapy caused by iron overload		at 1 year from study entry
Secondary	Length of the hospitalization		at 1 year from study entry
Secondary	Weeks of MDS suspension treatment		at 1 year from study entry
Secondary	Number of patients responding to therapy according to the administered treatment		at 1 year from study entry
Secondary	Number of MDS patients alive		at 1 year from study entry
Secondary	Number of patients without MDS progression		at 1 year from study entry
Secondary	Need for hospitalization		at 1 year from study entry
Secondary	Level transfusion dependence		At one year from study entry
Secondary	Level of MDS subtype		At one year from study entry
Secondary	Level of risk of International Prognostic Scoring System (IPSS)		At one year from study entry
Secondary	Level of International Prognostic Scoring System (IPSS)-revised		At one year from study entry
Secondary	Level of iron overload		At one year from study entry.

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