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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03140085
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Kessler, Balgrist University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intravesical Bacteriophage Treatment for Urinary Tract Infections Biological: PYO Phage Drug: Antibiotics Other: Sterile bacteriology media Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Bacteriophages for Treating Urinary Tract Infections in Patients Undergoing Transurethral Resection of the Prostate: A Randomized, Placebo-controlled, Double-blind Clinical Trial
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Anbiotica Drug: Antibiotics
Oral application
Active Comparator: Bacteriophages Biological: PYO Phage
Intravescial instillation
Placebo Comparator: Placebo Other: Sterile bacteriology media
Sterile bacteriology media, with identical color as bacteriophage preparation


Outcome Measures
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Primary Outcome Measures :
  1. Normalisation of urine culture [ Time Frame: 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 :
  1. Urine culture [ Time Frame: Baseline and 7 days after treatment ]
  2. Bladder diary [ Time Frame: Baseline and 7 days after treatment ]
    Assessment of number of voids, number of leakages, post void residual

  3. Pain diary [ Time Frame: Baseline and 7 days after treatment ]
    Visual analog scale (0 (no pain) to 10 (strongest possible pain))

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140085


Locations
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Georgia
National Center of Urology
Tbilisi, Georgia
Sponsors and Collaborators
Balgrist University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Kessler, Dr., Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT03140085    
Other Study ID Numbers: 02/283
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Anti-Bacterial Agents
Anti-Infective Agents