Clinical trial NCT03819712: Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
Official title: Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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:

  * A chronic inflammatory and/or autoimmune or allergic disease and in particular a chronic inflammatory disease of the intestine (Crohn's disease, ulcerative colitis), epidermis (psoriasis, atopic dermatitis), joints (rheumatoid arthritis), nervous system (multiple sclerosis), type I diabetes;
  * High blood pressure or type II diabetes;
  * A neurodegenerative disease.
* Subject who has been diagnosed with cancer and has not been in remission for more than 5 years.

Primary outcomes:
measure: TNF-α measurement in blood cell culture media using Luminex® technology.
timeFrame: At 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie
Study officials:
References: