Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections (Predict-UTI)
Primary Purpose
Urinary Tract Infections
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of blood samples
Collection of fecal samples
Collection of urine samples
Collection of vaginal swaps
Sponsored by
About this trial
This is an interventional basic science trial for Urinary Tract Infections
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.
Sites / Locations
- Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
No recurrent UTI
Recurrent UTI
Arm Description
Healthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03819712
First Posted
January 25, 2019
Last Updated
January 25, 2019
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03819712
Brief Title
Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
Acronym
Predict-UTI
Official Title
Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 28, 2019 (Anticipated)
Primary Completion Date
July 27, 2020 (Anticipated)
Study Completion Date
July 27, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No recurrent UTI
Arm Type
Experimental
Arm Description
Healthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years
Arm Title
Recurrent UTI
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Collection of blood samples
Intervention Description
23 mL of blood will be collected during the inclusion visit
Intervention Type
Other
Intervention Name(s)
Collection of fecal samples
Intervention Description
Fecal sample self-collected after the inclusion visit
Intervention Type
Other
Intervention Name(s)
Collection of urine samples
Intervention Description
10 mL of urine will be collected during the inclusion visit
Intervention Type
Other
Intervention Name(s)
Collection of vaginal swaps
Intervention Description
Sample of vaginal microbiota collected during the inclusion visit
Primary Outcome Measure Information:
Title
TNF-α measurement in blood cell culture media using Luminex® technology.
Description
The concentrations of TNF-α will be expressed in ng/ml by calibration with a standard range.
Time Frame
At 18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique MONDAIN, MD
Phone
+33 (0)4 92 03 77 77
Email
mondain.v@chu-nice.fr
Facility Information:
Facility Name
Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique MONDAIN, MD
Phone
+33 (0)4 92 03 77 77
Email
mondain.v@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
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