Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intravesical Bacteriophage Treatment for Urinary Tract Infections

Intervention / Treatment
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* Biological: PYO Phage
* Drug: Antibiotics
* Other: Sterile bacteriology media


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anbiotica<br> | Drug: Antibiotics<br>* Oral application<br>|
| Active Comparator: Bacteriophages<br> | Biological: PYO Phage<br>* Intravescial instillation<br>|
| Placebo Comparator: Placebo<br> | Other: Sterile bacteriology media<br>* Sterile bacteriology media, with identical color as bacteriophage preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalisation of urine culture | 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 | 7 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine culture |  | Baseline and 7 days after treatment | 
| Bladder diary | Assessment of number of voids, number of leakages, post void residual | Baseline and 7 days after treatment | 
| Pain diary | Visual analog scale (0 (no pain) to 10 (strongest possible pain)) | Baseline and 7 days after treatment | 
| IPSS questionnaire |  | Baseline and 7 days after treatment |