Urinary Tract InfectionsPredict-UTINCT03819712
Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
A study testing Collection of blood samples, Collection of fecal samples and Collection of urine samples in people with Urinary Tract Infections, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Collection of blood samples, Collection of fecal samples and Collection of urine samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie
Nice, 06200
About this study
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
- Being tested
- Collection of blood samples, Collection of fecal samples, Collection of urine samples, Collection of vaginal swaps
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samplesProcedure or surgery
23 mL of blood will be collected during the inclusion visit
Collection of fecal samplesOther
Fecal sample self-collected after the inclusion visit
Collection of urine samplesOther
10 mL of urine will be collected during the inclusion visit
Collection of vaginal swapsOther
Sample of vaginal microbiota collected during the inclusion visit
| Study group | Role | What they receive |
|---|---|---|
| No recurrent UTI | Experimental | Healthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years Receives: Procedure: Collection of blood samples; Other: Collection of fecal samples; Other: Collection of urine samples; Other: Collection of vaginal swaps |
| Recurrent UTI | Experimental | Not described Receives: Procedure: Collection of blood samples; Other: Collection of fecal samples; Other: Collection of urine samples; Other: Collection of vaginal swaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start3 Jun 2019
- Primary completion3 Dec 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819712
- Sponsor's protocol ID
- 18-PP-05
- Acronym
- Predict-UTI
- Status last verified
- Nov 2025
- First submitted
- 25 Jan 2019
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT03819712
- Acronym / sponsor ID
- Predict-UTI / 18-PP-05
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No recurrent UTI | Experimental | Procedure: Collection of blood samples, Other: Collection of fecal samples, Other: Collection of urine samples, Other: Collection of vaginal swapsHealthy female volunteer aged 18 to 28 years reporting a single cystitis since the age of 14 years |
| Recurrent UTI | Experimental | Procedure: Collection of blood samples, Other: Collection of fecal samples, Other: Collection of urine samples, Other: Collection of vaginal swaps |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood samples23 mL of blood will be collected during the inclusion visit | Procedure or surgery | No recurrent UTI, Recurrent UTI |
| Collection of fecal samplesFecal sample self-collected after the inclusion visit | Other | No recurrent UTI, Recurrent UTI |
| Collection of urine samples10 mL of urine will be collected during the inclusion visit | Other | No recurrent UTI, Recurrent UTI |
| Collection of vaginal swapsSample of vaginal microbiota collected during the inclusion visit | Other | No recurrent UTI, Recurrent UTI |
Primary outcome
TNF-α measurement in blood cell culture media using Luminex® technology.
Time frame: At 18 months
The concentrations of TNF-α will be expressed in ng/ml by calibration with a standard range.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of blood samples, Collection of fecal samples and Collection of urine samples in people with Urinary Tract Infections, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNF-α measurement in blood cell culture media using Luminex® technology. (time frame: At 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.