Status:
ACTIVE_NOT_RECRUITING
Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Urinary Tract Infections
Eligibility:
FEMALE
18-28 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03819712
Start Date
June 3 2019
End Date
December 31 2025
Last Update
December 3 2025
Active Locations (1)
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1
Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie
Nice, France, 06200