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Urinary tract infection (UTI) is one of the most common microbial diseases, which is a huge financial burden on society.
in the context of increasing antibiotic resistance, it is imperative to find UTI alternative therapies.
The study was a multi-center, randomized controlled trial of men over the age of 18 who planned to have a combined complex urinary tract infection (TURP) or a relapse of a simple urinary tract infection, but showed no signs of systemic infection, to determine whether bladder phage therapy with commercial phage cocktails was effective in treating UTI.
subjects were divided into three groups at 1:1:1 and given Pyo phages (Pyophage, 20 mL, 2/day x7) or placebo solution (20 mL) in the bladder or antibiotics throughout the body.
urine culture through the catheter at the end of treatment (i.e. day 7) or after exiting the trial.
prognosmological indicators are microbial therapy response after 7 days of treatment, and secondary indicators include clinical and safety parameters.
June 2, 2017 - December 14, 2018, 474 patients were screened, 113 of whom (24%) were randomly divided into three groups (37 in the Pyophage group, 32 in the placebo group, and 37 in the antibiotic group).
97 patients (28 in the Pyophage group, 32 in the placebo group and 37 in the antibiotic group) received at least one dose of the study drug, which was included in the main analysis.
there was no significant difference in treatment success rates between groups.
5 (18%), 9 (28%) and 13 (35%) patients in the Pyophage, placebo and antibiotic groups normalized urine culture.
Pyophage, placebo and antibiotic groups had 6 (21%), 13 (41%) and 11 (30%) adverse reactions, respectively.
bladder phage therapy is no less than standard antibiotic treatment, but for UTI patients treated with TURP, it is no better than placebo bladder flushing.
addition, phage safety is very beneficial.
Although phages have not yet become recognized or approved therapeutic options for UTI, the trial provides new insights into further optimizing the design of large-scale clinical studies to define the role of phages in UTI therapy.
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