search
Back to results

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

Primary Purpose

Intravesical Bacteriophage Treatment for Urinary Tract Infections

Status
Completed
Phase
Phase 2
Locations
Georgia
Study Type
Interventional
Intervention
PYO Phage
Antibiotics
Sterile bacteriology media
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intravesical Bacteriophage Treatment for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Center of Urology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Anbiotica

Bacteriophages

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Urine culture
Bladder diary
Assessment of number of voids, number of leakages, post void residual
Pain diary
Visual analog scale (0 (no pain) to 10 (strongest possible pain))
IPSS questionnaire

Full Information

First Posted
April 27, 2017
Last Updated
March 20, 2019
Sponsor
Balgrist University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03140085
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balgrist University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravesical Bacteriophage Treatment for Urinary Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anbiotica
Arm Type
Active Comparator
Arm Title
Bacteriophages
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
PYO Phage
Intervention Description
Intravescial instillation
Intervention Type
Drug
Intervention Name(s)
Antibiotics
Intervention Description
Oral application
Intervention Type
Other
Intervention Name(s)
Sterile bacteriology media
Intervention Description
Sterile bacteriology media, with identical color as bacteriophage preparation
Primary Outcome Measure Information:
Title
Normalisation of urine culture
Description
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
Time Frame
7 days after treatment
Secondary Outcome Measure Information:
Title
Urine culture
Time Frame
Baseline and 7 days after treatment
Title
Bladder diary
Description
Assessment of number of voids, number of leakages, post void residual
Time Frame
Baseline and 7 days after treatment
Title
Pain diary
Description
Visual analog scale (0 (no pain) to 10 (strongest possible pain))
Time Frame
Baseline and 7 days after treatment
Title
IPSS questionnaire
Time Frame
Baseline and 7 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
National Center of Urology
City
Tbilisi
Country
Georgia

12. IPD Sharing Statement

Citations:
PubMed Identifier
32949500
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.
Results Reference
derived
PubMed Identifier
28950849
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs