Intravesical Bacteriophage Treatment for Urinary Tract Infections
Conditions
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.
Interventions
BIOLOGICALPYO Phage
Intravescial instillation
DRUGAntibiotics
Oral application
OTHERSterile bacteriology media
Sterile bacteriology media, with identical color as bacteriophage preparation
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalisation of urine culture | 7 days after treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine culture | Baseline and 7 days after treatment | — |
| Bladder diary | Baseline and 7 days after treatment | Assessment of number of voids, number of leakages, post void residual |
| Pain diary | Baseline and 7 days after treatment | Visual analog scale (0 (no pain) to 10 (strongest possible pain)) |
| IPSS questionnaire | Baseline and 7 days after treatment | — |
Countries
Georgia
Outcome results
None listed