NCT03819712

Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: Female
• Age: 18 Years – 28 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
PROCEDURE	Collection of blood samples	23 mL of blood will be collected during the inclusion visit
OTHER	Collection of fecal samples	Fecal sample self-collected after the inclusion visit
OTHER	Collection of urine samples	10 mL of urine will be collected during the inclusion visit
OTHER	Collection of vaginal swaps	Sample of vaginal microbiota collected during the inclusion visit

Timeline

• Start date: 2019-06-03
• Primary completion: 2023-12-03
• Completion: 2025-12-31
• First posted: 2019-01-28
• Last updated: 2025-12-03

Locations

1 site across 1 country: France