Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Completed

Conditions: Myelodysplastic Syndrome

Treatments: Drug: Antibiotic and antifungal drugs

Study type: Observational

Funder types: Other

Identifiers

NCT01951430

MDS0413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

229 participants in 1 patient group

Myelodysplastic syndrome patients

Description:

Patients affected by myelodysplastic syndrome enrolled in the observational study

Treatment:

Drug: Antibiotic and antifungal drugs