Myelodysplasic Syndromes and Risk Factors for Infection (MYRIFIC)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: IPSS High Risk; Infection; Myelodysplastic Syndrome (MDS); Risk Factors

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02905552

NI13004

Details and patient eligibility

About

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

Full 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

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years old
• 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

• None

Trial design

320 participants in 2 patient groups

Case group

Description:

Patient developing a first episode of infection since diagnosis of high-risk MDS (index case)

Treatment:

Other: No intervention

Control group

Description:

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

Treatment:

Other: No intervention