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Myelodysplasic Syndromes and Risk Factors for Infection

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02905552
Acronym
MYRIFIC
Enrollment
320
Registered
2016-09-19
Start date
2016-09-30
Completion date
2018-09-30
Last updated
2016-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Myelodysplastic syndrome (myelodysplasia), Infection, Risk Factors

Brief 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

Interventions

OTHERNo intervention

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Occurrence of infectious episode12 months follow-up

Secondary

MeasureTime frame
severity of infectious episode12 months follow-up
Overall Survival (all-cause mortality)12months follow-up

Countries

France

Contacts

Primary ContactAndrea Toma, MD, PhD
andrea.toma@aphp.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026