UROVAXOM-P: Immunomodulation Therapy for Urinary Tract Infections

Sponsor

Swiss Paraplegic Centre Nottwil (Other)

Overall Status

Recruiting

CT.gov ID

NCT04049994

Collaborator

Swiss Spinal Cord Injury Cohort Study (SwiSCI) (Other), Swiss Paraplegic Research (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Urinary Tract Infections	Drug: Uro-Vaxom Drug: Placebo oral tablet	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

randomization rate [at study completion, an average of 2 years]
proportion of eligible patients who were enrolled

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,
other therapies for preventing UTIs (e.g. acidification of urine, cranberries),
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