An observational study in Urinary Tract Infections, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational
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).
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.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's planned enrollment of 210 is below the median of 236 across 198 observational studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 18 years
Exclusion Criteria:
Adults with community-acquired E. coli urinary tract infection classified as uncomplicated: asymptomatic bacteriuria or acute cystitis
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
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.
Genetic: 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.
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
Time frame: At the end of the 12-month inclusion period
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.
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.
sequence types by MLST, phylogroups)
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
by MLST/cgMLST typing and core-genome SNP phylogeny
Time frame: At the end of the 12-month inclusion period (genomic analysis of all stored isolates, performed after sequencing)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2029, 36 months later.
Of 72 non-industry observational studies under Urinary Tract Infections, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 36 months is below that.
Counting every sponsor, half of 83 studies reached it within 26 months; a quarter within 11 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de la Guadeloupe