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

Phase 2

Completed

• Conditions: Intravesical Bacteriophage Treatment for Urinary Tract Infections
• Interventions: Drug: Antibiotics; Biological: PYO Phage; Other: Sterile bacteriology media

• Registration Number: NCT03140085
• Lead Sponsor: Balgrist University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Study Start: 2017-06-02
• Primary Completion: 2018-12-14
• Study Completion: 2018-12-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anbiotica	Antibiotics	-
Bacteriophages	PYO Phage	-
Placebo	Sterile bacteriology media	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Center of Urology; 🇬🇪 Tbilisi, Georgia