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2017 ; 17
(1
): 90
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Bacteriophages for treating urinary tract infections in patients undergoing
transurethral resection of the prostate: a randomized, placebo-controlled,
double-blind clinical trial
#MMPMID28950849
Leitner L
; Sybesma W
; Chanishvili N
; Goderdzishvili M
; Chkhotua A
; Ujmajuridze A
; Schneider MP
; Sartori A
; Mehnert U
; Bachmann LM
; Kessler TM
BMC Urol
2017[Sep]; 17
(1
): 90
PMID28950849
show ga
BACKGROUND: 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. METHODS AND DESIGN: 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(4) 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. DISCUSSION: 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. TRIAL REGISTRATION: This study has been registered at clinicaltrials.gov
( www.clinicaltrials.gov/ct2/show/NCT03140085 ). April 27, 2017.
|*Bacteriophages/growth & development
[MESH]
|Double-Blind Method
[MESH]
|Humans
[MESH]
|Male
[MESH]
|Phage Therapy/*methods
[MESH]
|Transurethral Resection of Prostate/*adverse effects
[MESH]