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NCT Number: NCT04036097

Prospective Stratification of Infectious Risks in Multiple Sclerosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Department of Neurology

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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)

  2. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Bangerter-Rhyner Stiftung
  • Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany
  • Swiss Multiple Sclerosis Society

Registry information

Official study title

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

Acronym: InRIMS

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 29, 2019
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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