Antibiotic and antifungal drugs
DrugOther names: levofloxacine;, cyprofloxacine;, co-trimoxazole;, chinolones;, cephalosporins;, penicillines;, other betalactams;, macrolids;, posaconazole;, fluconazole;, itraconazole.
Completed
NCT Number: NCT01951430
Observational Evaluation of Infective Risk in Myelodysplastic Syndrome Patients
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Number of infectious events in myelodysplastic syndrome patients
Time frame: at 1 year from study entry
Infectious events are fungal and antibiotic events
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.
Sponsors and collaborators
Lead sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Other
Registry information
Official study title
Observational Prospective Multicenter Study to Evaluate the Infective Risk in Myelodysplastic Syndrome Patients: Antimicrobial Prophylaxis and Granulocyte Growth Factors.
Important dates
- Study start
- 2014
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Sep 26, 2013
- Registry last updated
- Sep 13, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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