Immunomodulation Therapy for Urinary Tract Infections (UROVAXOM-P)

Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation: a Randomized Controlled Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections; Spinal Cord Injuries
• Intervention / Treatment: Drug: Placebo oral tablet; Drug: Uro-Vaxom

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • LU
    • Nottwil, LU, Switzerland, 6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunomodulation; Lyophilized lysate of 18 E. coli strains (6 mg) for oral application. A treatment lasts 90 days (one capsule daily).	Drug: Uro-Vaxom; Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.
Placebo Comparator: Placebo; Oral placebo tablet once daily for 90 days.	Drug: Placebo oral tablet; Placebo oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
randomization rate	proportion of eligible patients who were enrolled	at study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive screening rate	proportion of eligible patients who were screened	at study completion, an average of 2 years
retention rate	treatment-specific retention rate	at study completion, an average of 2 years
drop-out rate	rate of enrolled study participants who do not complete the study protocol	at study completion, an average of 2 years
urine culture result	bacteria species isolated from urine of study participants	during follow-up of 12 months
change in urinary immunoglobulin A levels	concentration (mg/dl) of immunoglobulin A in the urine	time 0 and 12 months
count of urinary tract infection	occurrence of a symptomatic urinary tract infection	during follow-up of 12 months

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Collaborators: Swiss Spinal Cord Injury Cohort Study (SwiSCI)
• Investigators: Principal Investigator: Jürgen Pannek, Prof. Dr., Swiss Paraplegic Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): September 4, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: immunotherapy; immunomodulation; spinal cord injury; urinary tract infection; E. coli; immunostimulation; neurogenic lower urinary tract dysfunction; Uro-Vaxom
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Wounds and Injuries; Disease Attributes; Trauma, Nervous System; Spinal Cord Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections; Spinal Cord Injuries
• Other Study ID Numbers: 2018-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No