Immunomodulation Therapy for Urinary Tract Infections (UROVAXOM-P)

Swiss Paraplegic Research, Nottwil

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infections; Spinal Cord Injuries

Treatments: Drug: Placebo oral tablet; Drug: Uro-Vaxom

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT04049994

2018-22

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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,
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Immunomodulation

Experimental group

Description:

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

Treatment:

Drug: Uro-Vaxom

Placebo

Placebo Comparator group

Description:

Oral placebo tablet once daily for 90 days.

Treatment:

Drug: Placebo oral tablet