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Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients

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ClinicalTrials.gov Identifier: NCT01951430
Recruitment Status : Recruiting
First Posted : September 26, 2013
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Condition or disease Intervention/treatment
Myelodysplastic Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Prospective Multicenter Study to Evaluate the Infective Risk in Myelodysplastic Syndrome Patients: Antimicrobial Prophylaxis and Granulocyte Growth Factors.
Study Start Date : March 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of infectious events in myelodysplastic syndrome patients [ Time Frame: at 1 year from study entry ]
    Infectious events are fungal and antibiotic events


Secondary Outcome Measures :
  1. Number of MDS patients with a febrile event treated with antibiotic, antifungal and antiviral therapy [ Time Frame: at 1 year from study entry ]
  2. Level of neutropenia [ Time Frame: at 1 year from study entry ]
  3. Number of patients who recover from infection [ Time Frame: at 1 year from study entry ]
  4. 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 ]
  5. Number of patients who don't develop bacterial infection [ Time Frame: at 1 year from study entry ]
  6. Number of patient who don't develop fungal infection [ Time Frame: at 1 year from study entry ]
  7. Number of patient who don't develop viral infection [ Time Frame: at 1 year from study entry ]
  8. Number of patients that needed granulocyte growth factors [ Time Frame: at 1 year from study entry ]
  9. Number of patients that needed iron sequestrating therapy caused by iron overload [ Time Frame: at 1 year from study entry ]
  10. Length of the hospitalization [ Time Frame: at 1 year from study entry ]
  11. Weeks of MDS suspension treatment [ Time Frame: at 1 year from study entry ]
  12. Number of patients responding to therapy according to the administered treatment [ Time Frame: at 1 year from study entry ]
  13. Number of MDS patients alive [ Time Frame: at 1 year from study entry ]
  14. Number of patients without MDS progression [ Time Frame: at 1 year from study entry ]
  15. Need for hospitalization [ Time Frame: at 1 year from study entry ]
  16. Level transfusion dependence [ Time Frame: At one year from study entry ]
  17. Level of MDS subtype [ Time Frame: At one year from study entry ]
  18. Level of risk of International Prognostic Scoring System (IPSS) [ Time Frame: At one year from study entry ]
  19. Level of International Prognostic Scoring System (IPSS)-revised [ Time Frame: At one year from study entry ]
  20. Level of iron overload [ Time Frame: At one year from study entry. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult myelodysplastic syndrome patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951430


Contacts
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Contact: Paola Fazi, Dr. p.fazi@gimema.it
Contact: Enrico Crea e.crea@gimema.it

Locations
Show Show 25 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Livio Pagano, Dr. Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01951430    
Other Study ID Numbers: MDS0413
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Adult patients
Infective events
Antibiotic
Antifungal
Myelodysplastic syndrome
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antifungal Agents
Miconazole
Anti-Infective Agents
Antitubercular Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors