Urinary Tract InfectionsCOLIGENURINCT07905638
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
An observational study of Urinary Tract Infections, run by Centre Hospitalier Universitaire de la Guadeloupe.
Trial summary
The aim is to identify genomic determinants (genes or gene clusters) associated with the severity of community-acquired E. coli urinary tract infections in Guadeloupe through a comparative approach integrating clinical, microbiological, and genomic data (GWAS approach). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups)
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2029
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥ 18 years) born and living in Guadeloupe with a community-acquired urinary tract infection due to E. coli, managed at the CHU de la Guadeloupe between 1 March 2026 and 28 February 2027, for whom the E. coli isolate was stored (70 patients in each of 3 severity groups).
Who may be able to join
- Age ≥ 18 years
- Born and living in Guadeloupe
- Community-acquired urinary tract infection managed in one of the following units between 1 March 2026 and 28 February 2027: adult emergency department, gynecological emergency department, infectious diseases, adult intensive care, urology, nephrology, endocrinology, or post-emergency unit
- Positive urine culture (cytobacteriological examination of urine) for E. coli ≥ 10^3 CFU/mL
- E. coli isolate stored
- Patient (or relative/trusted person if the patient is unable to give agreement) who has not expressed opposition to participation in the study after being informed
Who cannot join
- Nosocomial or healthcare-associated urinary tract infection
- Polymicrobial culture
- Asymptomatic bacteriuria not meeting the diagnostic threshold of ≥ 10^5 CFU/mL
- Acute cystitis or febrile urinary tract infection not meeting the diagnostic threshold of ≥ 10^3 CFU/mL of E. coli
- Patient under a legal protection measure (guardianship or curatorship)
- Refusal of participation by the patient (or by the relative/trusted person if the patient is unable to give agreement)
- Deceased patient who expressed, during his/her lifetime, opposition to the use of his/her health data for scientific purposes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim is to identify genomic determinants (genes or gene clusters) associated with the severity of community-acquired E. coli urinary tract infections in Guadeloupe through a comparative approach integrating clinical, microbiological, and genomic data (GWAS approach).
Read the detailed description
Urinary tract infections (UTIs) are among the most common bacterial infections worldwide, with nearly 150 million cases each year. They affect individuals across all age groups and represent a substantial burden in terms of public health and economic costs. While most cases begin as mild cystitis, UTIs can progress to severe forms such as pyelonephritis or bacteremia, particularly in the presence of predisposing factors such as urinary stasis, catheterization, or biofilm formation.
The predominant etiological agent is Escherichia coli, especially its uropathogenic strains (UPEC). These strains differ from commensal intestinal E. coli by their extensive arsenal of virulence factors enabling colonization and persistence within the urinary tract. A central mechanism is adhesion to urothelial cells, mediated notably by P fimbriae and PapG adhesin variants, whose distribution is associated with tissue tropism (papGII in pyelonephritis, papGIII in cystitis). UPEC also evade host immunity through the formation of intracellular bacterial communities and the production of 180 toxins such as hemolysin HlyA and cytotoxic necrotizing factor 1 (CNF1), which promote invasion and bacterial dissemination.
A major concern is the emergence of highly virulent and resistant clones. The Sequence Type (ST) 131 lineage exemplifies this convergence, combining virulence factors, biofilm formation, and multidrug resistance, notably through the production of CTX-M-type extended-spectrum beta-lactamases carried on plasmids with high dissemination potential. These characteristics make ST131 a key driver of complicated UTIs and therapeutic failures, posing a critical global public health challenge.
In the French Caribbean, and particularly in Guadeloupe, data linking the genomic profiles of UPEC strains to the clinical severity of infections remain scarce. Identifying genomic signatures predictive of disease severity would enable better patient stratification at the time of diagnosis and facilitate early adaptation of management strategies (targeted antibiotic therapy, hospitalization, or closer monitoring). With the development of high-throughput sequencing, bioinformatics, and artificial intelligence tools, personalized, preventive, and more efficient medicine is becoming increasingly achievable. Furthermore, recent studies have revealed that certain environmental strains share important genetic similarities with human pathogenic clones, suggesting possible inter-reservoir circulation. These findings underscore the importance of an integrated One Health approach, as promoted by the World Health Organization (WHO), which emphasizes the interconnectedness of human, animal, and environmental health. In an insular territory such as Guadeloupe, characterized by high population density, strong anthropogenic pressures, and fragile ecosystems, this approach is particularly relevant to understanding local transmission dynamics and anticipating the emergence of multidrug-resistant and/or highly virulent strains.
- Conditions
- Urinary Tract Infections
- Being tested
- Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups)
- Keywords
- Urinary tract infections, bacteremia, Escherichia coli, antibiotic resistance genes
- Medical subject headings
- Urinary Tract Infections, Bacteremia, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups)Genetic
Illumina sequencing of the E. coli isolate stored from the index urine culture, followed by bioinformatic analysis: assembly (SPAdes), annotation (Prokka), virulence and resistance genes and mobile genetic elements (VFDB, ResFinder), MLST/cgMLST typing, core-genome SNP phylogeny and pan-GWAS. Performed on strains collected during routine care; no additional procedure for patients.
| Study group | Role | What they receive |
|---|---|---|
| Uncomplicated urinary tract infection | Adults with community-acquired E. coli urinary tract infection classified as uncomplicated: asymptomatic bacteriuria or acute cystitis Receives: Genetic: Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups) | |
| Febrile urinary tract infection without sepsis | Adults with community-acquired E. coli febrile urinary tract infection without sepsis: simple acute pyelonephritis, pyelonephritis at risk of complications, or febrile UTI in men Receives: Genetic: Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups) | |
| Febrile urinary tract infection with sepsis and/or septic shock | Adults with community-acquired E. coli febrile urinary tract infection with sepsis and/or septic shock (n = 70). For this group, the retrospective collection of stored isolates may be used, in addition to prospective inclusions, provided that the eligibility criteria defined in the protocol are met. This option aims to secure the feasibility of recruitment for these severe forms, whose frequency remains limited. Receives: Genetic: Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential frequency of virulence genes or gene clusters in E. coli isolates, compared according to the severity level of community-acquired urinary tract infection
pan-genome-wide association study
Measured: At the end of the 12-month inclusion period
Secondary outcomes (3)
Frequency and diversity of virulence and antibiotic resistance genes according to UTI severity (association between combined virulence/resistance profiles and severity levels)
Genes identified from whole-genome sequences using VFDB and ResFinder.
Measured: At the end of the 12-month inclusion period (genomic analysis of all stored isolates, performed after sequencing)]
Clonal characteristics of the uropathogenic E. coli isolates and their distribution according to severity of the cases.
sequence types by MLST, phylogroups)
Measured: : At the end of the 12-month inclusion period (genomic analysis of all stored isolates, performed after sequencing)
Genetic proximity between clinical and environmental E. coli isolates from Guadeloupe
by MLST/cgMLST typing and core-genome SNP phylogeny
Measured: At the end of the 12-month inclusion period (genomic analysis of all stored isolates, performed after sequencing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien BREUREC, Professor, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905638
- Sponsor's protocol ID
- CHUG_RIPH3_2026/03
- Acronym
- COLIGENURI
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
- ClinicalTrials.gov ID
- NCT07905638
- Acronym / sponsor ID
- COLIGENURI / CHUG_RIPH3_2026/03
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary tract infections, bacteremia, Escherichia coli, antibiotic resistance genes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 29 Oct 2026 (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.
The aim is to identify genomic determinants (genes or gene clusters) associated with the severity of community-acquired E. coli urinary tract infections in Guadeloupe through a comparative approach integrating clinical, microbiological, and genomic data (GWAS approach).
Detailed description
Urinary tract infections (UTIs) are among the most common bacterial infections worldwide, with nearly 150 million cases each year. They affect individuals across all age groups and represent a substantial burden in terms of public health and economic costs. While most cases begin as mild cystitis, UTIs can progress to severe forms such as pyelonephritis or bacteremia, particularly in the presence of predisposing factors such as urinary stasis, catheterization, or biofilm formation.
The predominant etiological agent is Escherichia coli, especially its uropathogenic strains (UPEC). These strains differ from commensal intestinal E. coli by their extensive arsenal of virulence factors enabling colonization and persistence within the urinary tract. A central mechanism is adhesion to urothelial cells, mediated notably by P fimbriae and PapG adhesin variants, whose distribution is associated with tissue tropism (papGII in pyelonephritis, papGIII in cystitis). UPEC also evade host immunity through the formation of intracellular bacterial communities and the production of 180 toxins such as hemolysin HlyA and cytotoxic necrotizing factor 1 (CNF1), which promote invasion and bacterial dissemination.
A major concern is the emergence of highly virulent and resistant clones. The Sequence Type (ST) 131 lineage exemplifies this convergence, combining virulence factors, biofilm formation, and multidrug resistance, notably through the production of CTX-M-type extended-spectrum beta-lactamases carried on plasmids with high dissemination potential. These characteristics make ST131 a key driver of complicated UTIs and therapeutic failures, posing a critical global public health challenge.
In the French Caribbean, and particularly in Guadeloupe, data linking the genomic profiles of UPEC strains to the clinical severity of infections remain scarce. Identifying genomic signatures predictive of disease severity would enable better patient stratification at the time of diagnosis and facilitate early adaptation of management strategies (targeted antibiotic therapy, hospitalization, or closer monitoring). With the development of high-throughput sequencing, bioinformatics, and artificial intelligence tools, personalized, preventive, and more efficient medicine is becoming increasingly achievable. Furthermore, recent studies have revealed that certain environmental strains share important genetic similarities with human pathogenic clones, suggesting possible inter-reservoir circulation. These findings underscore the importance of an integrated One Health approach, as promoted by the World Health Organization (WHO), which emphasizes the interconnectedness of human, animal, and environmental health. In an insular territory such as Guadeloupe, characterized by high population density, strong anthropogenic pressures, and fragile ecosystems, this approach is particularly relevant to understanding local transmission dynamics and anticipating the emergence of multidrug-resistant and/or highly virulent strains.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Uncomplicated urinary tract infection | – | Genetic: Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups)Adults with community-acquired E. coli urinary tract infection classified as uncomplicated: asymptomatic bacteriuria or acute cystitis |
| Febrile urinary tract infection without sepsis | – | Genetic: Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups)Adults with community-acquired E. coli febrile urinary tract infection without sepsis: simple acute pyelonephritis, pyelonephritis at risk of complications, or febrile UTI in men |
| Febrile urinary tract infection with sepsis and/or septic shock | – | Genetic: Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups)Adults with community-acquired E. coli febrile urinary tract infection with sepsis and/or septic shock (n = 70). For this group, the retrospective collection of stored isolates may be used, in addition to prospective inclusions, provided that the eligibility criteria defined in the protocol are met. This option aims to secure the feasibility of recruitment for these severe forms, whose frequency remains limited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥ 18 years) born and living in Guadeloupe with a community-acquired urinary tract infection due to E. coli, managed at the CHU de la Guadeloupe between 1 March 2026 and 28 February 2027, for whom the E. coli isolate was stored (70 patients in each of 3 severity groups).
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Born and living in Guadeloupe
- Community-acquired urinary tract infection managed in one of the following units between 1 March 2026 and 28 February 2027: adult emergency department, gynecological emergency department, infectious diseases, adult intensive care, urology, nephrology, endocrinology, or post-emergency unit
- Positive urine culture (cytobacteriological examination of urine) for E. coli ≥ 10^3 CFU/mL
- E. coli isolate stored
Key exclusion criteria (7 listed)
- Nosocomial or healthcare-associated urinary tract infection
- Polymicrobial culture
- Asymptomatic bacteriuria not meeting the diagnostic threshold of ≥ 10^5 CFU/mL
- Acute cystitis or febrile urinary tract infection not meeting the diagnostic threshold of ≥ 10^3 CFU/mL of E. coli
- Patient under a legal protection measure (guardianship or curatorship)
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 |
|---|---|---|
| Whole-genome sequencing (WGS) of E. coli isolates (applies to all 3 groups)Illumina sequencing of the E. coli isolate stored from the index urine culture, followed by bioinformatic analysis: assembly (SPAdes), annotation (Prokka), virulence and resistance genes and mobile genetic elements (VFDB, ResFinder), MLST/cgMLST typing, core-genome SNP phylogeny and pan-GWAS. Performed on strains collected during routine care; no additional procedure for patients. | Genetic | Febrile urinary tract infection with sepsis and/or septic shock, Febrile urinary tract infection without sepsis, Uncomplicated urinary tract infection |
Primary outcome
Differential frequency of virulence genes or gene clusters in E. coli isolates, compared according to the severity level of community-acquired urinary tract infection
Time frame: At the end of the 12-month inclusion period
pan-genome-wide association study
3 secondary outcomes
Frequency and diversity of virulence and antibiotic resistance genes according to UTI severity (association between combined virulence/resistance profiles and severity levels)
Time frame: At the end of the 12-month inclusion period (genomic analysis of all stored isolates, performed after sequencing)]
Clonal characteristics of the uropathogenic E. coli isolates and their distribution according to severity of the cases.
Time frame: : At the end of the 12-month inclusion period (genomic analysis of all stored isolates, performed after sequencing)
Genetic proximity between clinical and environmental E. coli isolates from Guadeloupe
Time frame: At the end of the 12-month inclusion period (genomic analysis of all stored isolates, performed after sequencing)
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 29 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Sébastien BREUREC, Professor principal investigator
CHU de la Guadeloupe
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Centre Hospitalier Universitaire de la Guadeloupe.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Sébastien BREUREC, Professor (+590 590 89 15 45, sebastien.breurec@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential frequency of virulence genes or gene clusters in E. coli isolates, compared according to the severity level of community-acquired urinary tract infection (time frame: At the end of the 12-month inclusion period). 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 29 Oct 2026.