Myelodysplasic Syndromes and Risk Factors for Infection (MYRIFIC)

December 20, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of infectious episode
Time Frame: 12 months follow-up
12 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
severity of infectious episode
Time Frame: 12 months follow-up
12 months follow-up
Overall Survival (all-cause mortality)
Time Frame: 12months follow-up
12months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Andrea Toma, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI13004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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