Immunomodulation Therapy for Urinary Tract Infections

NCT04049994 | Completed Phase 4

• 1 other identifier: 2018-22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary tract infections (UTI) represent one of the most common morbidities in individuals with spinal cord injury (SCI) and reason for re-hospitalization. The consequences of recurrent UTI are a decrease in quality of life and considerable health costs. Immunomodulation therapy with UroVaxom is a very promising method for the prevention of UTI, however data in individuals with SCI are very limited. The primary objective of this pilot study is to evaluate the feasibility (recruitment rate, patient attrition, compliance, assessment procedures etc.) of a main trial. A secondary objective is to collect data for an informed sample size calculation. Furthermore, the clinical and biological changes after immunomodulation therapy will be investigated. This is a randomized, placebo-controlled, mono-centric pilot study investigating the feasibility of a main trial regarding the effectiveness of immunomodulation with UroVaxom in the prevention of UTI and the effect on the immune system in individuals with acute SCI during primary rehabilitation. There will be two parallel groups of 12 participants each. Group allocation will be based on a block-randomization stratified according to sex. Study participants and outcome assessors will be blinded to the group allocation. The nursing staff will be unblinded and will administer the treatment and the placebo. Study participants will either receive Uro-Vaxom (one tablet / day) or an off-the-shelf placebo for 90 days. After termination of the treatment, the study participants will be followed for 12 months. Blood and urine samples will be taken before and 90 days, 6 months and 12 months after treatment start.

Conditions

Spinal Cord Injuries; Urinary Tract Infections

Keywords

spinal cord injury; neurogenic lower urinary tract dysfunction; urinary tract infection; immunotherapy; immunomodulation; immunostimulation; E. coli; Uro-Vaxom

Outcome Measures

Primary Outcomes (1)

• randomization rate

  proportion of eligible patients who were enrolled

  at study completion, an average of 2 years

Secondary Outcomes (6)

• positive screening rate

  at study completion, an average of 2 years

• retention rate

  at study completion, an average of 2 years

• drop-out rate

  at study completion, an average of 2 years

• urine culture result

  during follow-up of 12 months

• change in urinary immunoglobulin A levels

  time 0 and 12 months

Study Arms (2)

Immunomodulation

EXPERIMENTAL

Lyophilized lysate of 18 E. coli strains (6 mg) for oral application. A treatment lasts 90 days (one capsule daily).

Drug: Uro-Vaxom

Placebo

PLACEBO COMPARATOR

Oral placebo tablet once daily for 90 days.

Drug: Placebo oral tablet

Interventions

Uro-Vaxom DRUG

Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.

Immunomodulation

Placebo oral tablet DRUG

Placebo oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute SCI (within 8 weeks after SCI)
• onset of SCI within 72h
• age from 18 to 70 years
• informed consent as documented by signature

You may not qualify if:

• known hypersensitivity to investigational product,
• other immunomodulation therapy,
• immunosuppressant therapy,
• oncological condition or therapy,
• autoimmune diseases, nephropathy, bladder stones,
• women who are pregnant (pregnancy test) or breast feeding,
• participation in another study with an investigational drug within the 30 days preceding and during the present study

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• Swiss Spinal Cord Injury Cohort Study (SwiSCI): collaborator

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (2)

• Valido E, Bertolo A, Wollner J, Pannek J, Krebs J, Stoyanov J. Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot). Sci Rep. 2025 Apr 14;15(1):12825. doi: 10.1038/s41598-025-96939-y.

  PMID: 40229352 DERIVED

• Krebs J, Stoyanov J, Wollner J, Valido E, Pannek J. Immunomodulation for primary prevention of urinary tract infections in patients with spinal cord injury during primary rehabilitation: protocol for a randomized placebo-controlled pilot trial (UROVAXOM-pilot). Trials. 2021 Oct 4;22(1):677. doi: 10.1186/s13063-021-05630-w.

  PMID: 34607600 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Tract Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Jürgen Pannek, Prof. Dr.

  Swiss Paraplegic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: August 8, 2019
• Study Start: June 1, 2020
• Primary Completion: September 4, 2023
• Study Completion: October 31, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)