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Clinical Trials/NCT02905552
NCT02905552
Unknown
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country320 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myelodysplastic Syndrome (MDS)
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
320
Locations
1
Primary Endpoint
Occurrence of infectious episode
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
September 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Occurrence of infectious episode

Time Frame: 12 months follow-up

Secondary Outcomes

  • severity of infectious episode(12 months follow-up)
  • Overall Survival (all-cause mortality)(12months follow-up)

Study Sites (1)

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