Clinical trial NCT03140085: Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate
Official title: Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate: A Randomized, Placebo-controlled, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Intravesical Bacteriophage Treatment for Urinary Tract Infections
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients with urinary tract infections who are scheduled for transurethral resection of the prostate with urine culture (taken by mid-stream urine; or from the existing transurethral or suprapubic catheter) ≥104 colony forming units /mL of predefined uropathogens, including Enterococcus spp., Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus spp., and Streptococcus spp. and lower urinary tract symptoms such as urgency, frequency, dysuria, increased number of incontinence episodes
* Written informed consent.

Exclusion Criteria:

* Fever \>38°C
* CRP \>100mg/L
* Acute prostatitis
* Concomitant fungal urinary tract infection
* Current antibiotic treatment or antibiotic treatment within the last 7 days (exceptions: subjects with an active catheter associated urinary tract infection who have received prior antibiotics may be enrolled provided a minimum of 48 hours has elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for catheter associated urinary tract infection who present signs and symptoms consistent with an active new catheter associated infection may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture)
* Any rapidly progressing disease or immediately life-threatening illness including but not limited to: acute hepatic failure, respiratory failure, and septic shock
* No informed consent

Primary outcomes:
measure: Normalisation of urine culture
timeFrame: 7 days after treatment
Secondary outcomes:
measure: Urine culture
timeFrame: Baseline and 7 days after treatment
measure: Bladder diary
timeFrame: Baseline and 7 days after treatment
measure: Pain diary
timeFrame: Baseline and 7 days after treatment
measure: IPSS questionnaire
timeFrame: Baseline and 7 days after treatment
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: National Center of Urology
Study officials:
References:
citation: Leitner L, Ujmajuridze A, Chanishvili N, Goderdzishvili M, Chkonia I, Rigvava S, Chkhotua A, Changashvili G, McCallin S, Schneider MP, Liechti MD, Mehnert U, Bachmann LM, Sybesma W, Kessler TM. Intravesical bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomised, placebo-controlled, double-blind clinical trial. Lancet Infect Dis. 2021 Mar;21(3):427-436. doi: 10.1016/S1473-3099(20)30330-3. Epub 2020 Sep 16.
citation: Leitner L, Sybesma W, Chanishvili N, Goderdzishvili M, Chkhotua A, Ujmajuridze A, Schneider MP, Sartori A, Mehnert U, Bachmann LM, Kessler TM. Bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate: a randomized, placebo-controlled, double-blind clinical trial. BMC Urol. 2017 Sep 26;17(1):90. doi: 10.1186/s12894-017-0283-6.