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NCT Number: NCT04049994

Immunomodulation Therapy for Urinary Tract Infections

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uro-Vaxom

Drug

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

Placebo oral tablet

Drug

Placebo oral tablet

Primary outcomes

  1. randomization rate

    Time frame: at study completion, an average of 2 years

    proportion of eligible patients who were enrolled

Secondary outcomes

  1. positive screening rate

    Time frame: at study completion, an average of 2 years

    proportion of eligible patients who were screened

  2. retention rate

    Time frame: at study completion, an average of 2 years

    treatment-specific retention rate

  3. drop-out rate

    Time frame: at study completion, an average of 2 years

    rate of enrolled study participants who do not complete the study protocol

  4. urine culture result

    Time frame: during follow-up of 12 months

    bacteria species isolated from urine of study participants

  5. change in urinary immunoglobulin A levels

    Time frame: time 0 and 12 months

    concentration (mg/dl) of immunoglobulin A in the urine

  6. count of urinary tract infection

    Time frame: during follow-up of 12 months

    occurrence of a symptomatic urinary tract infection

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Collaborators

  • Swiss Spinal Cord Injury Cohort Study (SwiSCI)

Registry information

Official study title

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

Acronym: UROVAXOM-P

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2019
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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