Immunomodulation Therapy for Urinary Tract Infections

Spinal Cord Injuries Clinical Trial

— UROVAXOM-P  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049994
• Other study ID #: 2018-22
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Swiss Paraplegic Research, Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 31, 2023
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Spinal Cord Injuries
• Urinary Tract Infections

Intervention

Drug:
• Uro-Vaxom
Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.
• Placebo oral tablet
Placebo oral tablet

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Paraplegic Research, Nottwil	Swiss Spinal Cord Injury Cohort Study (SwiSCI)

Country where clinical trial is conducted

Switzerland, 

Outcome

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