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Enrolling by invitation NCT06724588

Analysis of Bacterial Multidrug Tolerance in Patients Prone to Urinary Tract Infections

Observational Patients with Recurrent or Chronic UTIs Patients with a Suprapubic Catheter Patients with a Nephrostomy Catheter

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Patients with Recurrent or Chronic UTIs, Patients with a Suprapubic Catheter, Patients with a Nephrostomy Catheter. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Systematic Analysis of Bacterial Multidrug Tolerance in Longitudinal Isolates of Patients That Are Prone to Developing Urinary Tract Infections

Overview

Prospective observational study aimed at collecting bacterial isolates from patients with recurrent or chronic UTIs, or patients with suprapubic or nephrostomy catheters.

Detailed description

In some cases, antibiotic therapy is not sufficient to clear bacterial infections. The reason for this is often a reduced sensitivity of the pathogens to the administered antibiotic. This sensitivity is largely determined by genetically encoded antibiotic resistance. In addition, bacterial populations also harbor a small fraction of phenotypic variants that are temporarily insensitive to the lethal effects of antibiotics. These so-called persister cells are formed by phenotypic transition from an antibiotic-sensitive 'normal' cell to an antibiotic-tolerant dormant state. On the other hand, persister cells can also return to the 'normal' state and resume growth, giving rise to the formation of a new population. Persistors represent an important but poorly understood clinical problem. For example, they play an underappreciated role in the failure of antimicrobial therapy in chronic infections. In addition, persisters contribute to the development of antibiotic resistance.

Little is known about how persistence evolves when bacteria are confronted with continuous or repeated antibiotic pressure. In silico predictions and previous in vitro work have shown that persister levels increase with frequent antibiotic exposure and that the period in the tolerant state is determined by the duration of treatment. We hypothesize that a similar evolutionary strategy occurs in vivo and that this contributes to the chronic nature of many infections. To support this hypothesis, we propose to collect longitudinal isolates from patients with recurrent or chronic UTIs. Since these patients visit the hospital at irregular and unpredictable time intervals, we will also collect isolates from patients with a suprapubic catheter. These patients do not necessarily suffer from chronic infections, but suprapubic catheters are usually colonized by microbial biofilms. We will also collect isolates from patients with a nephrostomy catheter. Similar to patients with suprapubic catheters, these patients visit the hospital regularly (± 6 weeks interval) for routine catheter changes and during these consultations, urine samples and catheter tips are easily collected. Furthermore, many of these patients are exposed to multiple antibiotic regimens (including, in the case of nephrostomy patients, high-dose cefazolin or ceftriaxone at the time of catheter change), creating a unique opportunity to study the evolution of antibiotic tolerance in a clinical setting.

Primary outcome measures

  • Collection of longitudinal bacterial strains to be used for fundamental research [Time frame: Per patient, 20 samples will be collected at 6-week intervals.]

Eligibility criteria

Inclusion criteria

  • Who are older than 18y
  • Who are of male or female sex
  • Who suffer from recurrent or chronic infections with or without neurological disorders (spina bifida, MS, paraplegic patients)
  • Who have or are planned to undergo the insertion of a suprapubic catheter
  • Who have or are planned to undergo the insertion of a nephrostomy catheter

Exclusion criteria

  • Who refused the planned treatment
  • Who are known to have poor therapy compliance
  • Who are pregnant
  • Who did not consent to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Identifiers

NCT: NCT06724588 · S65007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗