Prospective Stratification of Infectious Risks in Multiple Sclerosis

NCT ID: NCT04036097

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-10

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Multiple Sclerosis Society

UNKNOWN

Sponsor Role collaborator

Bangerter-Rhyner Stiftung

UNKNOWN

Sponsor Role collaborator

Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernhard Décard, Dr. med

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Department of Neurology

Locations

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University Hospital Basel, Department of Neurology

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2019-00465; me18Decard

Identifier Type: -

Identifier Source: org_study_id

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