Prospective Stratification of Infectious Risks in Multiple Sclerosis

NCT04036097 | Completed

• 1 other identifier: 2019-00465; me18Decard
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

secondary immunodeficiencies; disease-modifying treatments (DMT); immunosuppressive therapy; serious infection; respiratory tract infections (RTI); urinary tract infections; infection diary; Swiss MS Cohort (SMSC); SUMMIT (Serially Unified Multicenter Multiple Sclerosis Investigation) studies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs

  24 months

Interventions

MS-adapted AWIS questionnaire (MS-AWIS) OTHER

The predefined questionnaire-based infection score of the Airway Infection Susceptibility (AWIS) study is predictive for the occurrence of respiratory tract infections (RTI). In addition several MS-specific items (e.g. bladder dysfunction and urinary tract infections) are included into the AWIS questionnaire (MS-AWIS).

infection diary (MS-AWIS diary) OTHER

MS patients prospectively fill out monthly infection diaries for 24 months. Infection diaries will either be sent back (with pre-franked envelopes) or handed back to the InRIMS-study team during regular clinical visits (usually every 6 or 12 months).

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss Multiple Sclerosis Society: collaborator
• Bangerter-Rhyner Stiftung: collaborator
• Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany: collaborator

Study Sites (1)

University Hospital Basel, Department of Neurology

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis; Respiratory Tract Infections; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Infections; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Bernhard Décard, Dr. med

  University Hospital Basel, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: April 10, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

CH (1)