Prospective Stratification of Infectious Risks in Multiple Sclerosis

Overview

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.

Full Title of Study: “Prospective Stratification of Infectious Risks in Multiple Sclerosis (InRIMS-Study)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2023

Interventions

  • Other: MS-adapted AWIS questionnaire (MS-AWIS)
    • 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).
  • Other: infection diary (MS-AWIS diary)
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • AWIS RTI score
    • Time Frame: Baseline
    • 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)
  • infection diary score
    • Time Frame: 24 months
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Collaborator
    • Swiss Multiple Sclerosis Society
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bernhard Décard, Dr. med, Principal Investigator, University Hospital Basel, Department of Neurology

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