Myelodysplastic SyndromeNCT01951430
Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients
An observational study of Myelodysplastic Syndrome, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 25 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- Antibiotic and antifungal drugs
- How many people
- 229 participants
- Where
- 25 sitesItaly
- Study dates
- Mar 2014to 29 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult myelodysplastic syndrome patients
Who may be able to join
- All adult patients (>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation;
- Signed written informed consent;
Who cannot join
- Psychiatric patients;
- Patients with life expectancy less than three months.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Italy25 sites
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Azienda Ospedaliera - Nuovo Ospedale 'Torrette'
Ancona
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari
Divisione di Ematologia Ospedale A. Perrin
Brindisi
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari
Policlinico di Careggi
Florence
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
Genova
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Naples
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
Padova
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
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma
Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo
Pavia
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
Pesaro
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
Piacenza
U.O. di Ematologia - Centro Oncologico Basilicata
Rionero in Vulture
Complesso Ospedaliero S. Giovanni Addolorata
Roma
U.O.C. Ematologia - Ospedale S.Eugenio
Roma
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
Università degli Studi - Policlinico di Tor Vergata
Roma
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista
Torino
Clinica Ematologica-Centro Trapianti e Terapie cellulari Azienda Ospedaliero-Universitaria, Udine
Udine
About this study
Official title: 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.
Read the 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.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- Antibiotic and antifungal drugs
- Keywords
- Adult patients, Infective events, Antibiotic, Antifungal, Myelodysplastic syndrome
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic and antifungal drugsDrug
Also called levofloxacine;, cyprofloxacine;, co-trimoxazole;, chinolones;
| Study group | Role | What they receive |
|---|---|---|
| Myelodysplastic syndrome patients | Patients affected by myelodysplastic syndrome enrolled in the observational study Receives: Drug: Antibiotic and antifungal drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infectious events in myelodysplastic syndrome patients
Infectious events are fungal and antibiotic events
Measured: at 1 year from study entry
Secondary outcomes (20)
Number of MDS patients with a febrile event treated with antibiotic, antifungal and antiviral therapy
Measured: at 1 year from study entry
Level of neutropenia
Measured: at 1 year from study entry
Number of patients who recover from infection
Measured: 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
Measured: at 1 year from study entry
Number of patients who don't develop bacterial infection
Measured: at 1 year from study entry
Number of patient who don't develop fungal infection
Measured: at 1 year from study entry
Number of patient who don't develop viral infection
Measured: at 1 year from study entry
Number of patients that needed granulocyte growth factors
Measured: at 1 year from study entry
Number of patients that needed iron sequestrating therapy caused by iron overload
Measured: at 1 year from study entry
Length of the hospitalization
Measured: at 1 year from study entry
Weeks of MDS suspension treatment
Measured: at 1 year from study entry
Number of patients responding to therapy according to the administered treatment
Measured: at 1 year from study entry
Number of MDS patients alive
Measured: at 1 year from study entry
Number of patients without MDS progression
Measured: at 1 year from study entry
Need for hospitalization
Measured: at 1 year from study entry
Level transfusion dependence
Measured: At one year from study entry
Level of MDS subtype
Measured: At one year from study entry
Level of risk of International Prognostic Scoring System (IPSS)
Measured: At one year from study entry
Level of International Prognostic Scoring System (IPSS)-revised
Measured: At one year from study entry
Level of iron overload
Measured: At one year from study entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startMar 2014
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Livio Pagano, Dr., Principal investigator, Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951430
- Sponsor's protocol ID
- MDS0413
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2013
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Multicenter Study to Evaluate the Infective Risk in Myelodysplastic Syndrome Patients: Antimicrobial Prophylaxis and Granulocyte Growth Factors.
- ClinicalTrials.gov ID
- NCT01951430
- Acronym / sponsor ID
- MDS0413
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Adult patients, Infective events, Antibiotic, Antifungal, Myelodysplastic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myelodysplastic syndrome patients | – | Drug: Antibiotic and antifungal drugsPatients affected by myelodysplastic syndrome enrolled in the observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult myelodysplastic syndrome patients
Key inclusion criteria (2 listed)
- All adult patients (>18 years) with newly diagnosed myelodysplastic syndrome or patients who have undergone a bone marrow reevaluation;
- Signed written informed consent;
Key exclusion criteria (2 listed)
- Psychiatric patients;
- Patients with life expectancy less than three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic and antifungal drugsAlso: levofloxacine;, cyprofloxacine;, co-trimoxazole;, chinolones; | Drug | Myelodysplastic syndrome patients |
Primary outcome
Number of infectious events in myelodysplastic syndrome patients
Time frame: at 1 year from study entry
Infectious events are fungal and antibiotic events
20 secondary outcomes
Number of MDS patients with a febrile event treated with antibiotic, antifungal and antiviral therapy
Time frame: at 1 year from study entry
Level of neutropenia
Time frame: at 1 year from study entry
Number of patients who recover from infection
Time frame: 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
Time frame: at 1 year from study entry
Number of patients who don't develop bacterial infection
Time frame: at 1 year from study entry
Number of patient who don't develop fungal infection
Time frame: at 1 year from study entry
Number of patient who don't develop viral infection
Time frame: at 1 year from study entry
Number of patients that needed granulocyte growth factors
Time frame: at 1 year from study entry
Number of patients that needed iron sequestrating therapy caused by iron overload
Time frame: at 1 year from study entry
Length of the hospitalization
Time frame: at 1 year from study entry
Weeks of MDS suspension treatment
Time frame: at 1 year from study entry
Number of patients responding to therapy according to the administered treatment
Time frame: at 1 year from study entry
Number of MDS patients alive
Time frame: at 1 year from study entry
Number of patients without MDS progression
Time frame: at 1 year from study entry
Need for hospitalization
Time frame: at 1 year from study entry
Level transfusion dependence
Time frame: At one year from study entry
Level of MDS subtype
Time frame: At one year from study entry
Level of risk of International Prognostic Scoring System (IPSS)
Time frame: At one year from study entry
Level of International Prognostic Scoring System (IPSS)-revised
Time frame: At one year from study entry
Level of iron overload
Time frame: At one year from study entry.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Myelodysplastic Syndrome
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livio Pagano, Dr. principal investigator
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 25 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infectious events in myelodysplastic syndrome patients (time frame: at 1 year from study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.