Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS)

Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS-Study)

This monocentric study is to identify factors that increase the susceptibility for infections and establish a questionnaire-based infection score that allows a prospective stratification for infectious risks in patients with multiple sclerosis (MS) (InRIMS-Study). The study will utilize a validated, MS-adapted questionnaire and infection diary from the Airway Infection Susceptibility (AWIS) study in a regularly followed, prospective cohort of MS patients. It is a nested project of the prospective observational Swiss MS Cohort (SMSC) and SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: MS-adapted AWIS questionnaire (MS-AWIS); Other: infection diary (MS-AWIS diary)

• Study Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

• Study Contact: Name: Bernhard Décard, Dr. med; Phone Number: +41 61 265 4151; Email: bernhard.decard@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Department of Neurology

Participation Criteria

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

MS patients participating in the SMSC or SUMMIT study with or without DMT

Description

Inclusion Criteria:

• Signed informed consent form (ICF) for the InRIMS-study and Swiss MS Cohort (SMSC) and/or Serially Unified Multicenter Multiple Sclerosis Investigation (SUMMIT) study

Exclusion Criteria:

• Not able to sufficiently understand the patient information and questionnaire (German language)
• MS Patients with long-term antibiotic prophylaxis
• MS Patients with known primary immunodeficiency, under chemotherapy due to any malignancy or HIV infection.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AWIS RTI score	AWIS RTI score is based on the data collected with the MS-adapted AWIS (MS-AWIS) questionnaire; score varies between 0 (no RTI burden) and 50 (maximal RTI burden)	Baseline
infection diary score	monthly diary RTI score, averaging ten RTI symptom categories with the coding "0" for "no infection reported", "1" for "reported infection with duration < 2 weeks", and "2" for "reported infection present with duration >2 weeks	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs	Comparison of infection scores between patients receiving DMTs and those who do not receive DMTs	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss Multiple Sclerosis Society; Bangerter-Rhyner Stiftung; Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany
• Investigators: Principal Investigator: Bernhard Décard, Dr. med, University Hospital Basel, Department of Neurology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2019
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (ACTUAL): July 29, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: urinary tract infections; immunosuppressive therapy; secondary immunodeficiencies; disease-modifying treatments (DMT); serious infection; respiratory tract infections (RTI); infection diary; Swiss MS Cohort (SMSC); SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2019-00465; me18Decard

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No