Prospective Stratification of Infectious Risks in Multiple Sclerosis

University Hospital, Basel, Switzerland298 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

298

Conditions

Multiple Sclerosis

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 24 months

Secondary Outcomes

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