Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections

NCT03819712 | Active Not Recruiting

• 1 other identifier: 18-PP-05
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary tract infections affect more than 130 million people worldwide each year. Almost 50% of women will have at least one urinary tract infection during their lifetime, usually cystitis. Half of them will have recurrent cystitis. Antibiotics are the first-line treatment for cystitis, but their effectiveness is decreasing due to the rapid spread of multi-resistant uro-pathogenic bacteria. The objective of this study is to identify blood biomarkers associated with a high risk of recurrent cystitis. Immune system cells, and more specifically innate immunity cells, play a key role in controlling urinary tract infections. In addition, clinical studies have shown that there is a high inter-individual variability in the ability of innate immune cells to respond to different stimuli. We therefore hypothesized that there was an association between the risk of recurrent cystitis and a deficiency of certain immune cell types in producing certain pro-inflammatory cytokines, including TNF-α, in response to one or more bacterial stimuli, particularly flagellin.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• TNF-α measurement in blood cell culture media using Luminex® technology.

  The concentrations of TNF-α will be expressed in ng/ml by calibration with a standard range.

  At 18 months

Study Arms (2)

No recurrent UTI

EXPERIMENTAL

Healthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years

Procedure: Collection of blood samples; Other: Collection of fecal samples; Other: Collection of urine samples; Other: Collection of vaginal swaps

Recurrent UTI

EXPERIMENTAL

Procedure: Collection of blood samples; Other: Collection of fecal samples; Other: Collection of urine samples; Other: Collection of vaginal swaps

Interventions

Collection of blood samples PROCEDURE

23 mL of blood will be collected during the inclusion visit

No recurrent UTI; Recurrent UTI

Collection of fecal samples OTHER

Fecal sample self-collected after the inclusion visit

No recurrent UTI; Recurrent UTI

Collection of urine samples OTHER

10 mL of urine will be collected during the inclusion visit

No recurrent UTI; Recurrent UTI

Collection of vaginal swaps OTHER

Sample of vaginal microbiota collected during the inclusion visit

No recurrent UTI; Recurrent UTI

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female aged 18 to 28 years;
• Subject accepting to be serologically tested for HIV and HCV;
• Subject considered healthy by the physician on the basis of medical history and clinical examination;
• Subject with a body mass index between 18.5 and 30 kg/m2;
• Subject understands and speaks French and is able to give written consent;
• Subject affiliated to Social Security or a similar regime;
• Having reported a single cystitis since the age of 14 (Group 1), or 3 or more cystitis over a 12-month period since the age of 14 (Group 2).

You may not qualify if:

• Subject protected by law under guardianship or curatorship, or unable to participate in a clinical study under Article L. 1121-16 of the French Public Health Code;
• Subject who has participated in a clinical research study in the last 3 months in which he/she was exposed to a pharmaceutical product or medical device;
• Subject who has stayed in a tropical or subtropical country in the last 3 months;
• Pregnant or breastfeeding subject for women of childbearing age;
• Subject with special diet for medical reasons and prescribed by a doctor or dietician (e.g. a low-calorie diet or a diet intended to lower cholesterol levels);
• Subject who regularly consumes large quantities of alcohol, i. e. more than 50 g of pure alcohol per day (e. g. more than 4 glasses of 150 ml wine, more than 4 pints of 250 ml beer, or more than 4 glasses of 40 ml containing strong alcohol);
• Subject who has used an illegal recreational drug in the past 3 months;
• Subject who has taken an immunosuppressive or immunomodulatory drug (excluding intranasally or topically administered corticosteroids) in the past 2 weeks, or for more than 14 consecutive days in the past 6 months;
• Subject who has been vaccinated within the last 3 months;
• Subject who received a blood transfusion or immunoglobulins in the last 3 months;
• Subject stating that he has not been fasting for at least 10 hours;
• Subject reporting HIV or HCV status;
• Subject who had an infectious episode or was treated with antibiotics during the 4 weeks prior to the visit;
• Subject with a positive urinary pregnancy test;
• Subject with a severe and/or chronic and/or recurrent pathology, in particular:

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie

Nice, 06200, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 28, 2019
• Study Start: June 3, 2019
• Primary Completion: December 3, 2023
• Study Completion: December 31, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

FR (1)