Multicentre Prospective Observational Cohort Study Aiming... | NCT07485686

Studies
Multicentre Prospective Observational Cohort Study Aiming to Collect Medical Data, Create a Database to Facilitate Clinical and Fundamental Research Into Urinary Tract Infections With the Ultimate Goal of Improving Their Treatment.

NCT07485686

Sponsor

Angela HUTTNER

Status

Enrolling by invitation

Last Update Posted

Mar 20, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Urinary Tract Infection(UTI)
Urinary Tract Infection, Recurrent
UTI - Urinary Tract Infection

Interventions

Not provided

Countries

Germany
Netherlands
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
Agreement number: 2155009966	Other Grant/Funding Number	Innosuisse - Swiss Innovation Agency

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2023Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Mar 16, 2026

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 20, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 20, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Angela HUTTNER, Professor, Attending physician, Division of Infectious Diseases, University of Geneva, SwitzerlandSponsor-Investigator

Lead Sponsor

Angela HUTTNEROTHER

Collaborators

Name	Class
University Hospital, Geneva	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this prospective observational study is to collect epidemiological, clinical, microbiological, genetic, and behavioral data on individuals with UTIs. The goal is to better understand which interventions are effective and, subsequently, to facilitate studies that will improve our understanding of the condition, enhance patient care and relief, and help combat antimicrobial resistance. This project will enable us to study episodes of urinary tract infections over a period of at least 2 years and up to 5 years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total number of suspected and microbiologically confirmed urinary tract infections.	Yearly incidence of suspected and microbiologically confirmed UTI at 12 months among all patients initially presenting with lower urinary tract symptoms (LUTS) or upper urinary tract symptoms (UUTS).	From enrollment for a minimum of two years and a maximum of five years, with data collection at regular time points (2 months, 6 months, 12 months, 18 and 24 months after enrollment)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Urinary symptoms/signs suggestive of UTI (as determined by investigators), or a history of such symptoms/signs.

Exclusion Criteria:

Unwillingness to provide informed consent (for patients with capacity or for the representatives of those without capacity) and/or inability to provide informed consent (for patients without capacity and without representation).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients of any age or disposition (in- or outpatient) with a history of, or active, urinary symptoms suggestive of UTI or diagnosed with UTI are eligible for inclusion into SUTIC. Adult (≥18 years) sexual partners of included patients are also eligible.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angela Huttner, MD	Geneva University Hospitals, Geneva Faculty of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Frankfurt		Frankfurt			Germany
Leiden University Medical Center (LUMC)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases