Prospective Stratification of Infectious Risks in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04036097
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-29
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AWIS RTI score	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	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 Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Basel, Department of Neurology; 🇨🇭 Basel, Switzerland