Myelodysplasic Syndromes and Risk Factors for Infection
NCT ID: NCT02905552
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
320 participants
OBSERVATIONAL
2016-09-30
2018-09-30
Brief Summary
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The risk of leukemic transformation is estimated by the score IPSS (International Prognostic Score System). We distinguish the MDS of low risk (IPSS\<1) and those of high risk of leukemic transformation (IPSS=1,5).
Besides the risk of leukemic transformation, MDS much be complicated of infections which could be life-threatening.
The risk of developing first infection after the diagnosis of MDS of high risk is probably influenced by anamnestic (disease duration, comorbidities), clinical (veinous central catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin) and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions, anti-infectious preventive treatment) factors. Their identification will allow for improved targeting of the population which is is likely to benefit from anti-infective prophylaxis Primary objective is to identify risk factors associated with first acute episode of infection in patients with MDS, by comparing index cases and matched control cases who did not develop infection episode since diagnosis.
Secondary objectives are to explore nature and severity of infectious episodes, number of recurrences during 1 year of follow up and survival at 6 and 12 months
Detailed Description
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* Pairing according to age (+/- 5 years), sex and medical consultation date (+/-15 days)
* Follow up at M3, M6, M9 and M12
* Study duration : 24 months
* Inclusion duration : 12 months
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case group
Patient developing a first episode of infection since diagnosis of high-risk MDS (index case)
No intervention
Control group
Patient with no infection since diagnosis of MDS
Patient will be paired to index case by:
* Hospital site
* Age
* Sexe Control patient is eligible if he has been seen in consultation within 15days before or after date of first infection of index case If matching fails, control patient can be found in another site and/or within 30days before or after date of first infection of index case
No intervention
Interventions
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No intervention
Eligibility Criteria
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Inclusion Criteria
* MDS with IPSS \>1.5
* With a first infectious episode since the diagnosis of SMD of high risk (Case)
* Unhurt of any infection and being able to be mated in the case index (Control)
* Consulting or hospitalized in one of the services involved in the study during the period of inclusion
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Andrea Toma, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Henri Mondor Hospital
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Laetitia Grégoire
Role: primary
Other Identifiers
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NI13004
Identifier Type: -
Identifier Source: org_study_id