Clinical trial NCT02905552: Myelodysplasic Syndromes and Risk Factors for Infection
Official title: Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelodysplastic Syndrome (MDS)
Infection
Risk Factors
IPSS High Risk
Keywords: Myelodysplastic syndrome (myelodysplasia)
Infection
Risk Factors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with high-risk MDS (IPSS \> 1,5)

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

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:

* None

Primary outcomes:
measure: Occurrence of infectious episode
timeFrame: 12 months follow-up
Secondary outcomes:
measure: severity of infectious episode
timeFrame: 12 months follow-up
measure: Overall Survival (all-cause mortality)
timeFrame: 12months follow-up
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Andrea Toma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: