Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04049994
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunomodulation Therapy for Urinary Tract Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004927', 'term': 'Escherichia coli Infections'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D004756', 'term': 'Enterobacteriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'randomization rate', 'timeFrame': 'at study completion, an average of 2 years', 'description': 'proportion of eligible patients who were enrolled'}], 'secondaryOutcomes': [{'measure': 'positive screening rate', 'timeFrame': 'at study completion, an average of 2 years', 'description': 'proportion of eligible patients who were screened'}, {'measure': 'retention rate', 'timeFrame': 'at study completion, an average of 2 years', 'description': 'treatment-specific retention rate'}, {'measure': 'drop-out rate', 'timeFrame': 'at study completion, an average of 2 years', 'description': 'rate of enrolled study participants who do not complete the study protocol'}, {'measure': 'urine culture result', 'timeFrame': 'during follow-up of 12 months', 'description': 'bacteria species isolated from urine of study participants'}, {'measure': 'change in urinary immunoglobulin A levels', 'timeFrame': 'time 0 and 12 months', 'description': 'concentration (mg/dl) of immunoglobulin A in the urine'}, {'measure': 'count of urinary tract infection', 'timeFrame': 'during follow-up of 12 months', 'description': 'occurrence of a symptomatic urinary tract infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal cord injury', 'neurogenic lower urinary tract dysfunction', 'urinary tract infection', 'immunotherapy', 'immunomodulation', 'immunostimulation', 'E. coli', 'Uro-Vaxom'], 'conditions': ['Spinal Cord Injuries', 'Urinary Tract Infections']}, 'referencesModule': {'references': [{'pmid': '40229352', 'type': 'DERIVED', 'citation': 'Valido E, Bertolo A, Wollner J, Pannek J, Krebs J, Stoyanov J. Effects of Uro-Vaxom vs. placebo on the urinary tract microbiome in individuals with spinal cord injury in a randomized controlled pilot trial (Uro-Vaxom pilot). Sci Rep. 2025 Apr 14;15(1):12825. doi: 10.1038/s41598-025-96939-y.'}, {'pmid': '34607600', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute SCI (within 8 weeks after SCI)\n* onset of SCI within 72h\n* age from 18 to 70 years\n* informed consent as documented by signature\n\nExclusion Criteria:\n\n* known hypersensitivity to investigational product,\n* other immunomodulation therapy,\n* immunosuppressant therapy,\n* oncological condition or therapy,\n* autoimmune diseases, nephropathy, bladder stones,\n* women who are pregnant (pregnancy test) or breast feeding,\n* participation in another study with an investigational drug within the 30 days preceding and during the present study'}, 'identificationModule': {'nctId': 'NCT04049994', 'acronym': 'UROVAXOM-P', 'briefTitle': 'Immunomodulation Therapy for Urinary Tract Infections', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Immunomodulation Therapy for Primary Prevention of Urinary Tract Infections in Patients With Spinal Cord Injury During First Rehabilitation: a Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': '2018-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunomodulation', 'description': 'Lyophilized lysate of 18 E. coli strains (6 mg) for oral application. A treatment lasts 90 days (one capsule daily).', 'interventionNames': ['Drug: Uro-Vaxom']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral placebo tablet once daily for 90 days.', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Uro-Vaxom', 'type': 'DRUG', 'description': 'Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.', 'armGroupLabels': ['Immunomodulation']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Placebo oral tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}], 'overallOfficials': [{'name': 'Jürgen Pannek, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Paraplegic Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Swiss Spinal Cord Injury Cohort Study (SwiSCI)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}