Myelodysplasic Syndromes and Risk Factors for Infection

NCT02905552 | Unknown

• 1 other identifier: NI13004
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Myelodysplastic syndrome (myelodysplasia); Infection; Risk Factors

Outcome Measures

Primary Outcomes (1)

• Occurrence of infectious episode

  12 months follow-up

Secondary Outcomes (2)

• severity of infectious episode

  12 months follow-up

• Overall Survival (all-cause mortality)

  12months follow-up

Study Arms (2)

Case group

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

Other: No intervention

Control group

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

Other: No intervention

Interventions

No intervention OTHER

Case group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with high-risk MDS (IPSS \> 1,5)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes; Infections; Anemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Refractory; Anemia

Study Officials

• Andrea Toma, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Toma, MD, PhD

CONTACT

andrea.toma@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

FR (1)