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.
1 other identifier
observational
229
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2013
CompletedFirst Posted
Study publicly available on registry
September 26, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2020
CompletedSeptember 13, 2021
September 1, 2021
6.7 years
September 23, 2013
September 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of infectious events in myelodysplastic syndrome patients
Infectious events are fungal and antibiotic events
at 1 year from study entry
Secondary Outcomes (20)
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
- +15 more secondary outcomes
Study Arms (1)
Myelodysplastic syndrome patients
Patients affected by myelodysplastic syndrome enrolled in the observational study
Interventions
Eligibility Criteria
Adult myelodysplastic syndrome patients
You may qualify if:
- All adult patients (\>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation;
- Signed written informed consent;
You may not qualify if:
- Psychiatric patients;
- Patients with life expectancy less than three months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
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
Florence, 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
Padua, 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, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Livio Pagano, Dr.
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2013
First Posted
September 26, 2013
Study Start
March 1, 2014
Primary Completion
October 29, 2020
Study Completion
October 29, 2020
Last Updated
September 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share