Using enhanced aminoglycosides to prevent urinary tract infections after surgery
Metabolic Potentiation of Aminoglycosides: a Novel Antimicrobial Strategy to Prevent Urinary Tract Infections (UROPOT TRIAL).
This study is testing a new combination treatment to see if it can better prevent urinary tract infections after surgery in adults compared to the usual antibiotics.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne) |
| Trial ID | NCT05761405 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the effectiveness of a combination of aminoglycosides and mannitol compared to standard antibiotic prophylaxis for preventing urinary tract infections in adults undergoing endourological procedures with mucosal trauma. Participants with asymptomatic bacteriuria caused by E. coli or K. pneumoniae will be randomly assigned to receive either standard care or the new treatment. The primary goal is to determine if the new approach can prevent infectious complications within 48 hours post-operation, with a focus on non-inferiority to current standards. The study aims to address the challenge of antibiotic resistance and biofilm formation in urinary tract infections.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for endourological procedures who have asymptomatic bacteriuria caused by E. coli or K. pneumoniae sensitive to the study antibiotics.
Not a fit: Patients with antibiotic-resistant strains, other bacterial pathogens, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative urinary tract infections in patients undergoing endourological procedures.
How similar studies have performed: While the specific combination of mannitol and aminoglycosides is novel, similar approaches have shown promise in addressing antibiotic resistance in urinary tract infections.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Adults (≥18 years) * Ureteral stent in situ * Patients scheduled for endourological ureteral manipulations (e.g. endourological stone surgery, ureteral stent exchange) * Asymptomatic bacteriuria with strains of E. coli and/or K. pneumoniae sensitive to Ceftriaxone and Amikacin/Aminoglycosides. Exclusion Criteria: * Allergy to one of the study drugs Beta-lactams, aminoglycosides or mannitol * Pregnant and lactating women * Glomerular filtration rate (CKD-EPI eGFR) \< 50ml/min / 1,73m2 * Hearing impairment * Myasthenia gravis or other forms of myoneural disorders * Congestive heart failure, Pulmonary edema * Intracranial hemorrhage, blood-brain barrier compromise * Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial * Antibiotic treatment within 14 days prior to randomization * Mixed cultures of E. coli and/or K. pneumonia with other bacteria * Inability to understand and follow the protocol * Inability to give informed consent * BMI\<20 or \>30
Where this trial is running
Lausanne
- Chuv — Lausanne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Sylvain Meylan — Centre Hospitalier Universitaire Vaudois
- Study coordinator: Sylvain Meylan, MD-PhD
- Email: sylvain.meylan@chuv.ch
- Phone: +41795569418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.