Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndrome
• Intervention / Treatment: Drug: Antibiotic and antifungal drugs

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.

• Study Type: Observational
• Enrollment (Actual): 229

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy
    • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
  • Ancona, Italy
    • Azienda Ospedaliera - Nuovo Ospedale 'Torrette'
  • Bari, Italy
    • UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
  • Brindisi, Italy
    • Divisione di Ematologia Ospedale A. Perrin
  • Cagliari, Italy
    • ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
  • Firenze, Italy
    • Policlinico di Careggi
  • Genova, Italy
    • IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
  • Lecce, Italy
    • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
  • Napoli, Italy
    • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
  • Novara, Italy
    • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
  • Padova, Italy
    • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
  • Palermo, 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"
  • Parma, Italy
    • Cattedra di Ematologia CTMO Università degli Studi di Parma
  • Pavia, Italy
    • Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
  • Pesaro, Italy
    • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
  • Pescara, Italy
    • U.O. Ematologia Clinica - Azienda USL di Pescara
  • Piacenza, Italy
    • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
  • Rionero in Vulture, Italy
    • U.O. di Ematologia - Centro Oncologico Basilicata
  • Roma, 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
  • San Giovanni Rotondo, Italy
    • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
  • Torino, Italy
    • Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
  • Udine, Italy
    • Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult myelodysplastic syndrome patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Myelodysplastic syndrome patients; Patients affected by myelodysplastic syndrome enrolled in the observational study	Drug: Antibiotic and antifungal drugs; Other Names: levofloxacine;; cyprofloxacine;; co-trimoxazole;; chinolones;; cephalosporins;; penicillines;; other betalactams;; macrolids;; posaconazole;; fluconazole;; itraconazole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of infectious events in myelodysplastic syndrome patients	Infectious events are fungal and antibiotic events	at 1 year from study entry

Secondary Outcome Measures

Outcome Measure	Time Frame
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 recover from infection	at 1 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 patients who don't develop bacterial infection	at 1 year from study entry
Number of patient who don't develop fungal 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 that needed granulocyte growth factors	at 1 year from study entry
Number of patients that needed iron sequestrating therapy caused by iron overload	at 1 year from study entry
Length of the hospitalization	at 1 year from study entry
Weeks of MDS suspension treatment	at 1 year from study entry
Number of patients responding to therapy according to the administered treatment	at 1 year from study entry
Number of MDS patients alive	at 1 year from study entry
Number of patients without MDS progression	at 1 year from study entry
Need for hospitalization	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
Level of International Prognostic Scoring System (IPSS)-revised	At one year from study entry
Level of iron overload	At one year from study entry.

Collaborators and Investigators

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Investigators: Principal Investigator: Livio Pagano, Dr., Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 29, 2020
• Study Completion (Actual): October 29, 2020

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Antibiotic; Myelodysplastic syndrome; Adult patients; Antifungal; Infective events
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; 14-alpha Demethylase Inhibitors; Trypanocidal Agents; Cytochrome P-450 CYP2C9 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C19 Inhibitors; Anti-Bacterial Agents; Posaconazole; Antifungal Agents; Clotrimazole; Miconazole; Itraconazole; Fluconazole; Trimethoprim, Sulfamethoxazole Drug Combination; Cephalosporins
• Other Study ID Numbers: MDS0413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO