National Center of Urology
Tbilisi, Georgia
NCT Number: NCT03140085
Urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. The use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. Thus, the aim of this study is to investigate the efficacy of intravesical bacteriophage treatment to normalize urine culture compared to intravesical placebo or standard antibiotic treatment in a randomized controlled trial following a pilot phase.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Tbilisi, Georgia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravescial instillation
Oral application
Sterile bacteriology media, with identical color as bacteriophage preparation
Time frame: 7 days after treatment
Success of intravesical treatment, defined as normalization of urine culture (no evidence of bacteria, i.e. <104 colony forming units/mL) after 7 days of bacteriophage, placebo, or antibiotic treatment
Time frame: Baseline and 7 days after treatment
Time frame: Baseline and 7 days after treatment
Assessment of number of voids, number of leakages, post void residual
Time frame: Baseline and 7 days after treatment
Visual analog scale (0 (no pain) to 10 (strongest possible pain))
Time frame: Baseline and 7 days after treatment
Balgrist University Hospital
Other
Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate: A Randomized, Placebo-controlled, Double-blind Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.