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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03140085
• Date of registration: 27/04/2017
• Prospective Registration: Yes
• Primary sponsor: Balgrist University Hospital
• Public title: Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate
• Scientific title: Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate: A Randomized, Placebo-controlled, Double-blind Clinical Trial
• Date of first enrolment: June 2, 2017
• Target sample size: 97
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03140085
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 2/Phase 3

Countries of recruitment

Georgia

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intravesical Bacteriophage Treatment for Urinary Tract Infections

Intervention(s)

Biological: PYO Phage

Drug: Antibiotics

Other: Sterile bacteriology media

Primary Outcome(s)

Normalisation of urine culture [Time Frame: 7 days after treatment]

Secondary Outcome(s)

Pain diary [Time Frame: Baseline and 7 days after treatment]

IPSS questionnaire [Time Frame: Baseline and 7 days after treatment]

Urine culture [Time Frame: Baseline and 7 days after treatment]

Bladder diary [Time Frame: Baseline and 7 days after treatment]

Secondary ID(s)

02/283

Source(s) of Monetary Support

Please refer to primary and secondary sponsors