NCT02905552

Myelodysplasic Syndromes and Risk Factors for Infection

Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 320 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

* 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

Conditions

• Myelodysplastic Syndrome (MDS)
• Infection
• Risk Factors
• IPSS High Risk

Interventions

Type	Name	Description
OTHER	No intervention

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-09-01
• Completion: 2018-09-01
• First posted: 2016-09-19
• Last updated: 2016-12-21

Locations

1 site across 1 country: France