Infection Clinical Trial
Official title:
Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone
marrow failure and by a disorder of the medullary production which is a pre-leukemic state
which can evolve into acute myeloid leukemia.
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
- 160 couples (Case / Control)
- 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
;
Observational Model: Case Control, Time Perspective: Prospective
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