Prospective Stratification of Infectious Risks in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— InRIMS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04036097
• Other study ID #: 2019-00465; me18Decard
• Status: Active, not recruiting
• Start date: April 10, 2019
• Est. completion date: July 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 254
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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).
• 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).

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Neurology	Basel

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Bangerter-Rhyner Stiftung, Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany, Swiss Multiple Sclerosis Society

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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