Myelodysplasic Syndromes and Risk Factors for Infection

Infection Clinical Trial

— MYRIFIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02905552
• Other study ID #: NI13004
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2016
• Last updated: December 20, 2016
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: December 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Andrea Toma, MD, PhD
• Email: andrea.toma[@]aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• IPSS High Risk
• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Risk Factors
• Syndrome

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of infectious episode		12 months follow-up	No
Secondary	severity of infectious episode		12 months follow-up	No
Secondary	Overall Survival (all-cause mortality)		12months follow-up	No