Bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomized, placebo-controlled, double-blind clinical trial

• Published in: BMC urology Vol. 17; no. 1; p. 90
• Main Authors: Leitner, Lorenz, Sybesma, Wilbert, Chanishvili, Nina, Goderdzishvili, Marina, Chkhotua, Archil, Ujmajuridze, Aleksandre, Schneider, Marc P, Sartori, Andrea, Mehnert, Ulrich, Bachmann, Lucas M, Kessler, Thomas M
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 26-09-2017; BioMed Central; BMC
• Subjects: Antibiotic resistance; Antibiotics; Antimicrobial agents; Bacterial infections; Bacteriophages; Bacteriophages - growth & development; Bladder; Care and treatment; Clinical medicine; Clinical trials; Double-Blind Method; Double-blind studies; E coli; Escherichia coli; Health aspects; Humans; Male; Microorganisms; Nosocomial infections; Pain; Phage Therapy - methods; Phages; Physiological aspects; Prostate; Pseudomonas aeruginosa; Randomized placebo-controlled double-blind trial; Resistance; Studies; Study Protocol; Success; Transurethral Resection of Prostate - adverse effects; Treatment Outcome; Urinalysis; Urinary bladder; Urinary tract; Urinary tract diseases; Urinary tract infection; Urinary tract infections; Urinary Tract Infections - diagnosis; Urinary Tract Infections - etiology; Urinary Tract Infections - therapy; Urine; Urogenital system; Urology; Switzerland; Bacteriophages; Resistance; Urinary tract infection; Antibiotics; Randomized placebo-controlled double-blind trial
• ISSN: 1471-2490; 1471-2490
• DOI: 10.1186/s12894-017-0283-6

Urinary tract infections (UTI) are among the most prevalent microbial diseases and their financial burden on society is substantial. The continuing increase of antibiotic resistance worldwide is alarming. Thus, well-tolerated, highly effective therapeutic alternatives are urgently needed. Although there is evidence indicating that bacteriophage therapy may be effective and safe for treating UTIs, the number of investigated patients is low and there is a lack of randomized controlled trials.
This study is the first randomized, placebo-controlled, double-blind trial investigating bacteriophages in UTI treatment. Patients planned for transurethral resection of the prostate are screened for UTIs and enrolled if in urine culture eligible microorganisms ≥10
colony forming units/mL are found. Patients are randomized in a double-blind fashion to the 3 study treatment arms in a 1:1:1 ratio to receive either: a) bacteriophage (i.e. commercially available Pyo bacteriophage) solution, b) placebo solution, or c) antibiotic treatment according to the antibiotic sensitivity pattern. All treatments are intended for 7 days. No antibiotic prophylaxes will be given to the double-blinded treatment arms a) and b). As common practice, the Pyo bacteriophage cocktail is subjected to periodic adaptation cycles during the study. Urinalysis, urine culture, bladder and pain diary, and IPSS questionnaire will be completed prior to and at the end of treatment (i.e. after 7 days) or at withdrawal/drop out from the study. Patients with persistent UTIs will undergo antibiotic treatment according to antibiotic sensitivity pattern.
Based on the high lytic activity and the potential of resistance optimization by direct adaptation of bacteriophages, and considering the continuing increase of antibiotic resistance worldwide, bacteriophage therapy is a very promising treatment option for UTIs. Thus, our randomized controlled trial investigating bacteriophages for treating UTIs will provide essential insights into this potentially revolutionizing treatment option.
This study has been registered at clinicaltrials.gov ( www.clinicaltrials.gov/ct2/show/NCT03140085 ). April 27, 2017.